Non-animal replacement methods for veterinary vaccine potency testing: state of the science and future directions

Jodie Kulpa-Eddy; Geetha Srinivas; Marlies Halder; Richard Hill; Karen Brown; James Roth; Hans Draayer; Jeffrey Galvin; Ivo Claassen; Glen Gifford; Ralph Woodland; Vivian Doelling; Brett Jones; William S Stokes

doi:10.1016/j.provac.2011.10.005

. 2011 Dec 23;5:60–83. doi: 10.1016/j.provac.2011.10.005

Non-animal replacement methods for veterinary vaccine potency testing: state of the science and future directions

Jodie Kulpa-Eddy ^a, Geetha Srinivas ^b, Marlies Halder ^c, Richard Hill ^b, Karen Brown ^d, James Roth ^e, Hans Draayer ^f, Jeffrey Galvin ^f, Ivo Claassen ^g, Glen Gifford ^h, Ralph Woodland ⁱ, Vivian Doelling ^j, Brett Jones ^j, William S Stokes ^k,^⁎

PMCID: PMC7129755 PMID: 32288914

Abstract

NICEATM and ICCVAM convened an international workshop to review the state of the science of human and veterinary vaccine potency and safety testing methods and to identify opportunities to advance new and improved methods that can further reduce, refine, and replace animal use. Six topics were addressed in detail by speakers and workshop participants and are reported in a series of six reports. This workshop report, the second in the series, provides recommendations for current and future use of non-animal methods and strategies for veterinary vaccine potency testing. Workshop participants recommended that future efforts to replace animal use give priority to vaccines (1) that use large numbers of animals per test and for which many serials are produced annually, (2) that involve significant animal pain and distress during procedures, (3) for which the functional protective antigen has been identified, (4) that involve foreign animal/zoonotic organisms that are dangerous to humans, and (5) that involve pathogens that can be easily spread to wildlife populations. Vaccines identified as the highest priorities were those for rabies, Leptospira spp., Clostridium spp., Erysipelas, foreign animal diseases (FAD), poultry diseases, and fish diseases. Further research on the identification, purification, and characterization of vaccine protective antigens in veterinary vaccines was also identified as a priority. Workshop participants recommended priority research, development, and validation activities to address critical knowledge and data gaps, including opportunities to apply new science and technology. Recommendations included (1) investigations into the relative impact of various adjuvants on antigen quantification assays, (2) investigations into extraction methods that could be used for vaccines containing adjuvants that can interfere with antigen assays, and (3) review of the current status of rabies and tetanus human vaccine in vitro potency methods for their potential application to the corresponding veterinary vaccines. Workshop participants recommended enhanced international harmonization and cooperation and closer collaborations between human and veterinary researchers to expedite progress. Implementation of the workshop recommendations is expected to advance alternative in vitro methods for veterinary vaccine potency testing that will benefit animal welfare and replace animal use while ensuring continued protection of human and animal health.

Keywords: veterinary vaccines, vaccine potency testing, vaccine safety testing, replacement alternatives, ICCVAM

References

1.Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The NICEATM-ICCVAM five-year plan (2008-2012): a plan to advance alternative test methods of high scientific quality to protect and advance the health of people, animals, and the environment. National Institute of Environmental Health Sciences, 2008. NIH Publication No. 08-6410. http://iccvam.niehs.nih.gov/docs/5yearplan.htm.
2.Stokes W.S., Kulpa-Eddy J., McFarland R.M. Introduction and summary of the international workshop on alternative methods to reduce, refine, and replace the use of animals in vaccine potency and safety testing: state of the science and future directions. Proc Vaccinol. 2011;5:1–15. [Google Scholar]
3.McFarland R., Verthelyi D., Casey W., Arciniega J., Isbrucker R., Schmitt M., Finn T., Descamps J., Horiuchi Y., Sesardic D., Stickings P., Johnson N.W., Lipscomb E., Allen D. Non-animal replacement methods for human vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol. 2011;5:16–32. doi: 10.1016/j.provac.2011.10.002. [DOI] [PMC free article] [PubMed] [Google Scholar]
4.Kulpa-Eddy J., Srinivas G., Halder M., Hill R., Brown K., Roth J., Draayer H., Galvin J., Claassen I., Gifford G., Woodland R., Doelling V., Jones B., Stokes W.S. Non-animal replacement methods for veterinary vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol. 2011;5:60–83. doi: 10.1016/j.provac.2011.10.005. [DOI] [PMC free article] [PubMed] [Google Scholar]
5.Casey W., Schmitt M., McFarland R., Isbrucker R., Levis R., Arciniega J., Descamps J., Finn T., Hendriksen C., Horiuchi Y., Keller J., Kojima H., Sesardic D., Stickings P., Johnson N.W., Lipscomb E., Allen D. Improving animal welfare and reducing and refining animal use for human vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol. 2011;5:33–46. doi: 10.1016/j.provac.2011.10.002. [DOI] [PMC free article] [PubMed] [Google Scholar]
6.Stokes W.S., Brown K., Kulpa-Eddy J., Srinivas G., Halder M., Draayer H., Galvin J., Claassen I., Gifford G., Woodland R., Doelling V., Jones B. Improving animal welfare and reducing animal use for veterinary vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol. 2011;5:84–105. doi: 10.1016/j.provac.2011.10.005. [DOI] [PMC free article] [PubMed] [Google Scholar]
7.Isbrucker R., Levis R., Casey W., McFarland R., Schmitt M., Arciniega J., Descamps J., Finn T., Hendriksen C., Horiuchi Y., Keller J., Kojima H., Sesardic D., Stickings P., Johnson N.W., Allen D. Alternative methods and strategies to reduce, refine, and replace animal use for human vaccine post-licensing safety testing: state of the science and future directions. Proc Vaccinol. 2011;5:47–59. doi: 10.1016/j.provac.2011.10.002. [DOI] [PMC free article] [PubMed] [Google Scholar]
8.Kulpa-Eddy J., Srinivas G., Halder M., Hill R., Brown K., Draayer H., Galvin J., Claassen I., Gifford G., Woodland R., Doelling V., Jones B., Stokes W.S. Alternative methods and strategies to reduce, refine, and replace animal use for veterinary vaccine post-licensing safety testing: state of the science and future directions. Proc Vaccinol. 2011;5:106–119. doi: 10.1016/j.provac.2011.10.005. [DOI] [PMC free article] [PubMed] [Google Scholar]
9.Roth J. Veterinary vaccines and their importance to animal health and public health. Proc Vaccinol. 2011;5:127–136. doi: 10.1016/j.provac.2011.10.009. [DOI] [PMC free article] [PubMed] [Google Scholar]
10.Schuchat A. Human vaccines and their importance to public health. Proc Vaccinol. 2011;5:120–126. doi: 10.1016/j.provac.2011.10.009. [DOI] [PMC free article] [PubMed] [Google Scholar]
11.Finn T. U. S. FDA Requirements for human vaccine safety and potency testing. Proc Vaccinol. 2011;5:137–140. doi: 10.1016/j.provac.2011.10.002. [DOI] [PMC free article] [PubMed] [Google Scholar]
12.Hill R.E. USDA requirements for veterinary vaccine safety and potency testing. Proc Vaccinol. 2011;5:141–145. [Google Scholar]
13.Isbrucker R., Sontakke S., Smith D. Health Canada's human vaccine lot release program: impact on the 3Rs. Proc Vaccinol. 2011;5:147–150. [Google Scholar]
14.Woodland R. European regulatory requirements for veterinary vaccine safety and potency testing and recent progress toward reducing animal use. Proc Vaccinol. 2011;5:151–155. [Google Scholar]
15.Horiuchi Y., Ochiai M., Kataoka M., Yamamoto A., Yuen C.-T., Asokanathan C., Corbel M., Kurata T., Xing D. Strategic approaches for developing alternative tests for safety and potency of vaccines. Proc Vaccinol. 2011;5:156–163. [Google Scholar]
16.Shin J., Lei D., Conrad C., Knezevic I., Wood D. International Regulatory Requirements for Vaccine Safety and Potency Testing: A WHO perspective. Proc Vaccinol. 2011;5:164–170. [Google Scholar]
17.Draayer H. Overview of currently approved veterinary vaccine potency testing methods and methods in development that do not require animal use. Proc Vaccinol. 2011;5:171–174. [Google Scholar]
18.Claassen I. Case study of development, validation, and acceptance of a non-animal method for assessing veterinary vaccine potency. Proc Vaccinol. 2011;5:175–183. [Google Scholar]
19.Levis R. Overview of the current status of human vaccine potency testing methods that replace animals. Presented at: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions. NICEAM. Bethesda, MD. September 2010. Available at: http://iccvam.niehs.nih.gov/meetings/BiologicsWksp-2010/BiologicsWksp-present.htm.
20.Descamps J. A Case study of development, validation, and acceptance of a non-animal method for assessing human vaccine potency. Proc Vaccinol. 2011;5:184–191. [Google Scholar]
21.Keller J.E. Overview of currently approved serological methods with a focus on diphtheria and tetanus toxoid potency testing. Proc Vaccinol. 2011;5:192–199. [Google Scholar]
22.Srinivas G. Refinement alternatives for veterinary vaccine potency testing: overview of currently approved serological methods. Presented at: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions. NICEAM. Bethesda, MD. September 2010. Available at: http://iccvam.niehs.nih.gov/meetings/BiologicsWksp-2010/BiologicsWksp-present.htm.
23.Stickings P., Rigsby P., Coombes L., Hockley J., Tierney R., Sesardic D. Animal refinement and reduction: alternative approaches for potency testing of diphtheria and tetanus vaccines. Proc Vaccinol. 2011;5:200–212. [Google Scholar]
24.Arciniega J.L., Domínguez-Castillo R.I. Development and validation of serological methods for human vaccine potency testing: case study of an anthrax vaccine. Proc Vaccinol. 2011;5:213–220. [Google Scholar]
25.Hendriksen C.F.M. Humane endpoints in vaccine potency testing. Proc Vaccinol. 2011;5:221–226. [Google Scholar]
26.Kulpa-Eddy J., Srinivas G. Approaches to reducing animal numbers in vaccine potency testing. Proc Vaccinol. 2011;5:227–231. doi: 10.1016/j.provac.2011.10.005. [DOI] [PMC free article] [PubMed] [Google Scholar]
27.Kulpa-Eddy J., Dusek D. Application of the consistency approach in the United States to reduce animal use in vaccine potency testing. Proc Vaccinol. 2011;5:232–235. [Google Scholar]
28.Gifford G., Agrawal P., Hutchings D., Yarosh O. Veterinary vaccine post-licensing safety testing: overview of current regulatory requirements and accepted alternatives. Proc Vaccinol. 2011;5:236–247. [Google Scholar]
29.Arciniega J.L., Corvette L., Hsu H., Lynn F., Romani T., Dobbelaer R. Target alternative vaccine safety testing strategies for Pertussis toxin. Proc Vaccinol. 2011;5:248–260. [Google Scholar]
30.Rubin S.A. Toward replacement of the monkey neurovirulence test in vaccine safety testing. Proc Vaccinol. 2011;5:261–265. [Google Scholar]
31.United States Public Law 430 of 1913 and Public Law 99-198 (1985 amendments to the Virus-Serum-Toxin Act); Title 21 U.S. Code, Chapter 5 §§ 151 et. seq.
32.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.108. SAM 207: Supplemental Assay Method for Potency Testing Clostridium novyi Type B Alpha Antigen. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.
33.European Pharmacopoeia. Monograph 01/2010:0362. Clostridium novyi (type B) vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2010.
34.EDQM. Alternative potency testing and other possible related quality issues for veterinary clostridial vaccines. Pharmeuropa, 1997 Special Issue, Bio 97-1. Strasbourg, France: European Department for the Quality of Medicines.
35.Hendriksen C., Spieser J.M., Akkermans A., Balls M., Bruckner L., Cussler K., Daas A., Descamps J., Dobbelaer R., Fentem J., Halder M., van der Kamp M., Lucken R., Milstien J., Sesardic D., Straughan D., Valadares A. Validation of alternative methods for the potency testing of vaccines: the report and recommendations of ECVAM workshop 31. ALTA. 1998;26:747–761. [PubMed] [Google Scholar]
36.European Pharmacopoeia. Monograph 01/2008:0364. Clostridium septicum vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
37.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.111. SAM 201: Supplemental Assay Method for Potency Testing of Clostridium perfringens Type C Beta Antigen. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.
38.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.112. SAM 203: Supplemental Assay Method for Potency Testing of Clostridium perfringens Type D Epsilon Antigen. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.
39.European Pharmacopoeia. Monograph 01/2008:0363. Clostridium perfringens vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
40.Rosskopf-Streicher U., Johannes S., Wilhelm M., Cussler K. Quality control of inactivated erysipelas vaccines: results of an international collaborative study to establish a new regulatory test. Vaccine. 2001;19:1477–1483. doi: 10.1016/s0264-410x(00)00346-7. [DOI] [PubMed] [Google Scholar]
41.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.109. SAM 212: Supplemental Assay Method for Potency Testing of Clostridium sordellii Antigen. 2010.
42.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.107. SAM 209: Supplemental Assay Method for Potency Testing Products Containing Clostridium haemolyticum Antigen. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.
43.United States Department of Agriculture, Center for Veterinary Biologics, SAM 206: Supplemental Assay Method for Potency Testing Tetanus Antitoxins. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.
44.United States Department of Agriculture, Center for Veterinary Biologics, SAM 217: Supplemental Assay Method for Potency Testing Tetanus Toxoid by ELISA. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.
45.European Pharmacopoeia. Monograph 01/2008:0697. Tetanus Vaccine for Veterinary Use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
46.Council of Europe. 2.7.8 Assay of Tetanus vaccine (adsorbed). European Pharmacopoeia. 1996. Strasbourg, France: Council of Europe.
47.Hendriksen C., Woltjes J., Akkermans A.M., van der Gun J.W., Marsman F.R., Verschure M.H., Veldman K. Interlaboratory validation of the in vitro serological assay systems to assess the potency of tetanus toxoid in vaccines for veterinary use. Biologicals. 1994;22:257–268. doi: 10.1006/biol.1994.1037. [DOI] [PubMed] [Google Scholar]
48.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.103. SAM 625: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar canicola Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
49.European Pharmacopoeia. Monograph 01/2008:0447. Canine Leptospirosis vaccine (inactivated). 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
50.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products, Part 113 – Standard Requirements, Section 113.105. Leptospira Hardjo Bacterin. http://www.access.gpo.gov/nara/cfr/waisidx_09/9cfr113_09.html.
51.European Pharmacopoeia. Monograph 01/2008:1939. Bovine leptospirosis vaccine (inactivated). 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
52.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.209. SAM 308: Supplemental Assay Method for Potency Testing of Inactivated Rabies Vaccines in Mice Using the National Institutes of Health Test. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
53.European Pharmacopoeia. Monograph XXXX: 0451 – Rabies vaccine (inactivated) for veterinary use. Pharmeuropa 2011;13:128-131.
54.Cliquet F., Aubert M., Sange L. Development of a florescent antibody virus neutralization test (FAVN test) for the quantitation of rabies-neutralising antibody. Journal of Immunological Methods. 1998;212:79–87. doi: 10.1016/s0022-1759(97)00212-3. [DOI] [PubMed] [Google Scholar]
55.Kramer B., Schildger H., Behrensdorf-Nicol H.A., Hanschmann K.M., Duchow K. The rapid fluorescent focus inhibition test is a suitable method for batch potency testing of inactivated rabies vaccines. Biologicals. 2009;37(2):119–126. doi: 10.1016/j.biologicals.2009.01.001. [DOI] [PubMed] [Google Scholar]
56.Kramer B., Bruckner L., Daas A., Milne C. Collaborative study for validation of a serological potency assay for rabies vaccine (inactivated) for veterinary use. Pharmeuropa Bio. 2010:37–55. [PubMed] [Google Scholar]
57.Nagarajan T., Reddy G.S., Mohana Subramanian B., Rajalakshmi S., Thiagarajan D., Tordo N., Jallet C., Srinivasan V.A. A simple immuno-capture ELISA to estimate rabies viral glycoprotein antigen in vaccine manufacture. Biologicals. 2006;34:21–27. doi: 10.1016/j.biologicals.2005.07.004. [DOI] [PubMed] [Google Scholar]
58.Golde W.T., Pacheco J.M., Duque H., Doel T., Penford B., Ferman G.S., Gregg D.R., Rodriguez L.L. Vaccination against foot and mouth disease virus confers complete clinical protection in 7 days and partial protection in 4 days: Use in emergency outbreak response. Vaccine. 2005;23:5775–5782. doi: 10.1016/j.vaccine.2005.07.043. [DOI] [PubMed] [Google Scholar]
59.Rodriguez L.L., Grubman M.J. Foot and mouth disease virus vaccines. Vaccine. 2009;27:D90–D94. doi: 10.1016/j.vaccine.2009.08.039. [DOI] [PubMed] [Google Scholar]
60.Hendriksen C., Replacement reduction and refinement alternatives to animal use in vaccine potency measurement. Expert Rev Vaccines. 2008;8(3):313–322. doi: 10.1586/14760584.8.3.313. [DOI] [PubMed] [Google Scholar]
61.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.67. SAM 612: Supplemental Assay Method for Bacterial Plate Count of Erysipelothrix rhusiopathiae Vaccines. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
62.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.68. SAM 905: Supplemental Assay Method for Test for Potency of Live Avirulent Pasteurella haemolytica Vaccine. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_900_series.shtml.
63.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.71. SAM 319: Supplemental Assay Method for Titration of Chlamydophila felis (formerly Feline Chlamydia psittaci) in Embryonated Chicken Eggs. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
64.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.314. SAM 306: Supplemental Assay Method for the Titration of Feline Calicivirus in Cell Culture. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
65.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.315. SAM 307: Supplemental Assay Method for the Titration of Feline Rhinotracheitis Virus in Cell Culture. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
66.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.330. SAM 406: Supplemental Assay Method for Titration of Monovalent, Cell Associated Marek's Disease Vaccines of Serotypes 1, 2 or 3. 2005. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_400_series.shtml.
67.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 114: Supplemental Assay Method for Titration of Porcine Transmissible Gastroenteritis Virus. 2011. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_100_series.shtml.
68.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 121: Supplemental Assay Method for Titration of Porcine Rotovirus In Modified-Live Vaccines. 2005. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_100_series.shtml.
69.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.305. SAM 304: Supplemental Assay Method for Titration of Infectious Canine Hepatitis Virus in Primary Canine Kidney Cell Culture. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
70.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 317: Supplemental Assay Method for Titration of Canine Adenovirus in Canine Kidney Cell Culture. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
71.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.331. SAM 408: Supplemental Assay Method for Titrating Tissue Culture Adapted Vaccine Strains of Infectious Bursal Disease Virus. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_400_series.shtml.
72.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.304. SAM 305: Supplemental Assay Method for Titration of Feline Panleukopenia Virus in Cell Culture. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
73.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.307. SAM 316: Supplemental Assay Method for Titration of Canine Parvovirus in Cell Culture. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
74.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.302. SAM 303: Supplemental Assay Method for the Titration of Distemper Virus in Embryonated Chicken Eggs. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
75.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 320: Supplemental Assay Method for Titration of Chlamydophilia felis (formerly Feline Chlamydia psittaci) in Embryonated Chicken Eggs. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
76.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 411: Supplemental Assay Method for the Titration of Newcastle Disease-Infectious Bronchitis Vaccine in Chicken Embryos. 2011. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_400_series.shtml.
77.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.301. Ovine Ecthyma Vaccine.
78.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.119. SAM 613: Supplemental Assay Method for In vitro Potency Testing of Erysipelothrix rhusiopathiae Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
79.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 620-623: Supplemental Assay Method for Potency Testing Enterotoxigenic (K99, K 88, 987P, F41 Pilus) Escherichia coli Bacterins. 2009.http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
80.Johannes S., Hartinger J., Hendriksen C.F.M., Morton D.B., Cussler K. Humane endpoints in the efficacy testing of swine erysipelas vaccines. ALTEX. 2003;20:11–15. [PubMed] [Google Scholar]
81.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.101. SAM 624: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar pomona Bacterins. 2009.http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
82.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.104. SAM 626: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar grippotyphosa Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
83.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.102. SAM 627: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar icterohaemorrhagiae Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
84.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 120: Supplemental Assay Method for the in vitro Potency Assay of Bovine Respiratory Viruses in Killed Vaccines. 1991. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_100_series.shtml.
85.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 321: Supplemental Assay Method for Quantitating the GP70 Antigen of Feline Leukemia Virus in Veterinary Vaccines. 2007 http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
86.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 322: Supplemental Assay Method for Determination of the Specific Viral Antigen Content in Inactivated Canine Coronavirus Vaccines. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
87.Maas R.A., de Winter M.P.M., Venema S., Oei H.L., Claassen I.J.T.M. Antigen quantification as in vitro alternative for potency testing of inactivation viral poultry vaccines. Vet Quart. 2000;22:223–227. doi: 10.1080/01652176.2000.9695063. [DOI] [PubMed] [Google Scholar]
88.Claassen I., Maas R., Oei H., Daas A., Milne C. Validation study to evaluate the reproducibility of a candidate in vitro potency assay of Newcastle disease vaccines and to establish the suitability of a candidate biological reference preparation. Pharmeuropa Bio. 2004;1:1–15. [PubMed] [Google Scholar]
89.Liljebjelke K.A., King D.J., Kapczynski D.R. Determination of minimum hemagglutinin units in an inactivated Newcastle disease virus vaccine for clinical protection of chickens from exotic Newcastle disease virus challenge. Avian Diseases. 2008;52:260–268. doi: 10.1637/8154-101907-Reg.1. [DOI] [PubMed] [Google Scholar]
90.Maas R.A., Komen M., van Diepen M., Oei H.L., Claassen I.J.T.M. Correlation of haemagglutinin-neuraminidase and fusion protein content with protective antibody response after immunisation with inactivated Newcastle disease vaccines. Vaccine. 2003;21(23):3136–3141. doi: 10.1016/s0264-410x(03)00249-4. [DOI] [PubMed] [Google Scholar]
91.Claassen I., Maas R., Oei H., Daas A., Milne C. Feasibility study to evaluate the correlation between results of a candidate in vitro assay and established in vivo assays for potency determination of Newcastle disease vaccines. Pharmeuropa Biol. 2003;1:53–65. [PubMed] [Google Scholar]
92.Kross I. Redhead K. Perspectives from industry: development of alternative test for quality control testing of veterinary vaccines. EDQM Proceedings; Alternatives to Animal Testing: New Approaches in the Development and Control of Biologicals; Dubrovnik, Croatia. 2008.
93.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.65. SAM 600: Supplemental Assay Method for Purity, Potency and Dissociation of Brucella abortus Vaccine, Strain l9. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
94.European Pharmacopoeia. Monograph 01/2008:0589. Marek's disease vaccine (live). 7th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2010.
95.European Pharmacopoeia. Monograph 01/2008:0587. Avian infectious bursal disease vaccine (live). 7th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2010.
96.Thornton D.H. Standard requirements for vaccines against infectious bursal disease. Dev Biol Stand. 1976;33:343–348. [PubMed] [Google Scholar]
97.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.119. SAM 611: Supplemental Assay Method for Potency Testing of Erysipelas Bacterins in Mice. 2008 http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
98.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.101. SAM 608: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar pomona Bacterins. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
99.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.103. SAM 609: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar canicola Bacterins. 2008 http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
100.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.104. SAM 617: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar grippotyphosa Bacterins. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
101.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.102. SAM 610: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar icterohaemorrhagiae Bacterins. 2008 http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
102.United States Department of Agriculture, Center for Veterinary Biologics, Veterinary Services Memorandum 800.104. In Vitro Serial Release Potency Test for Completed Product Containing Clostridium chauvoei. 2003. http://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo_800_104.pdf.
103.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 220. Not available.
104.European Pharmacopoeia. Monograph 01/2008:0361. Clostridium chauvoei Vaccine for Veterinary Use. 5th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
105.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.216. Bovine Rhinotracheitis, Killed Virus. http://edocket.access.gpo.gov/cfr_2003/9cfr113.216.htm.
106.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.115. Staphylococcus Aureus Bacterin-Toxoid. 2002. http://edocket.access.gpo.gov/cfr_2002/janqtr/9cfr113.115.htm.
109.Hendriksen C. Three Rs achievements in vaccinology. AATEX Special Issue. 2007;14:575–579. [Google Scholar]
110.Jagt H.J.M., Bekkers M.L.E., Bommel S.A.J.T., Marel P., Schrier C.C. The influence of the inactivating agent on the antigen content of inactivated Newcastle disease vaccines assessed by the in vitro potency test. Biologicals. 2010;38:128–134. doi: 10.1016/j.biologicals.2009.07.006. [DOI] [PubMed] [Google Scholar]
111.United States Department of Agriculture, Center for Veterinary Biologics, Veterinary Services Memorandum 800.112. Guidelines for Validation of In Vitro Potency Assays. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo_800_112.pdf.
112.Barth R., Diderrich G., Weinmann E. NIH test, a problematic method for testing potency of inactivated rabies vaccine. Vaccine. 1988;6:369–377. doi: 10.1016/0264-410x(88)90185-5. [DOI] [PubMed] [Google Scholar]
113.Wunderli P.S., Dreesen D.W., Miller T.J., Baer G.M. Effects of vaccine route and dosage on protection from rabies after intracerebral challenge in mice. Am J Vet Med. 2003;64:491–498. doi: 10.2460/ajvr.2003.64.491. [DOI] [PubMed] [Google Scholar]
114.Wunderli P.S., Dreesen D.W., Miller T.J., Baer G.M. The rabies peripheral challenge test: more accurate determination of vaccine potency. Vaccine. 2006;24:7115–7123. doi: 10.1016/j.vaccine.2006.06.078. [DOI] [PubMed] [Google Scholar]
115.Smith JS, Yager PA, Baer GM. A rapid tissue culture test for determining rabies neutralising antibody. In: Meslin F-X, Kaplan MM, Hoprowski H, editors. Laboratory Techniques in Rabies. Geneva, Switzerland, World Trade Organization, 1996;4:354-357. [PubMed]
116.Bruckner L., Cussler K., Halder M., Barrat J., Castle P., Duchow K., Gatewood D.M., Gibert R., Groen J., Knapp B., Levis R., Milne C., Parker S., Stünkel K., Visser N., Volkers P. Three Rs approaches in the quality control of inactivated rabies vaccines. The report and recommendations of ECVAM Workshop 48. ALTA. 2003;31:429–454. doi: 10.1177/026119290303100409. [DOI] [PubMed] [Google Scholar]
117.Jennings M., Morton D., Charton E., Cooper J., Hendriksen C., Martin S., Pearce M., Price S., Redhead K., Reed N., Simmons H., Spencer S., Willingale H. Application of the Three Rs to challenge assays used in vaccine testing: Tenth report of the BVAAWF/FRAME/RSPCA/UFAW Joint Working Group on Refinement. Biologicals. 2010;38:684–695. doi: 10.1016/j.biologicals.2010.04.004. [DOI] [PubMed] [Google Scholar]
118.Lyng J., Benzton M.W., Ferguson M., Fitzgerald E.A. Rabies vaccine standardization: international collaborative study for the characterization of the fifth international standard for rabies vaccine. Biologicals. 1992;20:301–313. doi: 10.1016/s1045-1056(05)80051-x. [DOI] [PubMed] [Google Scholar]
119.European Pharmacopoeia. Monograph 04/2008:0216. Rabies Vaccine for Human Use Prepared in Cell Culture. 5th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
120.Metz B., Brunel F., Chamberlin C., van der Gun J., Halder M., Jiskoot W., Kersten G., van Opstal O., Petersen J.W., Ravetkar S.D., Redhead K., Schwanig M., Wilhelmsen E.S., Vann W.F., Hendriksen C. The potential of physiochemical and immunochemical assays to replace animal tests in the quality control of toxoid vaccines. The report and recommendations of ECVAM Workshop 61. ATLA. 2007;35:323–331. doi: 10.1177/026119290703500307. [DOI] [PubMed] [Google Scholar]
121.Piersma S.J., Leenaars M., Guzylack-Piriou L., Summerfield A., Hendriksen C., McCullough K. An in vitro immune response model to determine tetanus toxoid antigen (vaccine) specific immunogenicity: selection of sensitive assay criteria. Vaccine. 2006;24:3076–3083. doi: 10.1016/j.vaccine.2006.01.061. [DOI] [PubMed] [Google Scholar]
122.Barnett P.V., Carabin H. A review of emergency foot-and-mouth disease (FMD) vaccines. Vaccine. 2002;20:1505–1514. doi: 10.1016/s0264-410x(01)00503-5. [DOI] [PubMed] [Google Scholar]
123.Grubman M.J. Development of novel strategies to control foot-and-mouth disease: Marker vaccines and antivirals. Biologicals. 2005;33:227–234. doi: 10.1016/j.biologicals.2005.08.009. [DOI] [PubMed] [Google Scholar]
124.Rodriguez L.L., Grubman M.J. Foot and mouth disease virus vaccines. Vaccine. 2009;27:D90–D94. doi: 10.1016/j.vaccine.2009.08.039. [DOI] [PubMed] [Google Scholar]
125.Paton D.J., Sumption K.J., Charleston B. Options for the control of foot-and-mouth disease: knowledge, capability and policy. Phil Trans R Soc B. 2009;364:2657–2667. doi: 10.1098/rstb.2009.0100. [DOI] [PMC free article] [PubMed] [Google Scholar]
126.Li Z., Liu J. The current state of vaccines used in the field for foot and mouth disease virus in China. Expert Rev Vaccines. 2011;10:13–15. doi: 10.1586/erv.10.146. [DOI] [PubMed] [Google Scholar]
127.Golde W.T., Pacheco J.M., Duque H., Doel T., Penford B., Ferman G.S., Gregg D.R., Rodriguez L.L. Vaccination against foot and mouth disease virus confers complete clinical protection in 7 days and partial protection in 4 days: Use in emergency outbreak response. Vaccine. 2005;23:5775–5782. doi: 10.1016/j.vaccine.2005.07.043. [DOI] [PubMed] [Google Scholar]
128.Meeusen E.N., Walker J., Peters A., Pastoret P., Jungersen G. Current status of veterinary vaccines. Clinical Microbiology Reviews. 2007;20:489–510. doi: 10.1128/CMR.00005-07. [DOI] [PMC free article] [PubMed] [Google Scholar]
129.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 406. Supplemental Assay Method for Titration of Monovalent, Cell Associated Marek's Disease Vaccines of Serotypes 1, 2, or 3. 2011. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_400_series.shtml.
130.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 408. Supplemental Assay Method for Titrating Tissue Culture Adapted Vaccine Strains of Infectious Bursal Disease Virus. 2005. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_400_series.shtml.
131.Oei H., Maas R., Venema S., Kant A., Claassen I. Quantification of infectious Bursal Disease viral proteins 2 and 3 in inactivated vaccines as an indicator of serological responses and as a measure of potency. Avian Pathol. 2004;33(2):126–132. doi: 10.1080/03079450310001652121. [DOI] [PubMed] [Google Scholar]
132.Reitan L.J., Secombes C.J. In vitro methods for vaccine evaluation. Dev Biol Stand. 1997;90:293–301. [PubMed] [Google Scholar]
133.Shao Z. Aquaculture pharmaceuticals and biologicals: current perspectives and future possibilities. Advanced Drug Delivery Reviews. 2001;50:229–243. doi: 10.1016/s0169-409x(01)00159-4. [DOI] [PubMed] [Google Scholar]
134.Anderson D.P. Adjuvants and immunostimulants for enhancing vaccine potency in fish. Salmon Bay Biologicals. 1997;90:257–265. [PubMed] [Google Scholar]
135.United States Department of Agriculture, Center for Veterinary Biologics, Veterinary Services Memorandum 800.90. Guidelines for Veterinary Biological Relative Potency Assays and Reference Preparations Based on ELISA Antigen Quantification. 1998.http://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo_800_90.pdf.

[bib0005] 1.Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The NICEATM-ICCVAM five-year plan (2008-2012): a plan to advance alternative test methods of high scientific quality to protect and advance the health of people, animals, and the environment. National Institute of Environmental Health Sciences, 2008. NIH Publication No. 08-6410. http://iccvam.niehs.nih.gov/docs/5yearplan.htm.

[bib0010] 2.Stokes W.S., Kulpa-Eddy J., McFarland R.M. Introduction and summary of the international workshop on alternative methods to reduce, refine, and replace the use of animals in vaccine potency and safety testing: state of the science and future directions. Proc Vaccinol. 2011;5:1–15. [Google Scholar]

[bib0015] 3.McFarland R., Verthelyi D., Casey W., Arciniega J., Isbrucker R., Schmitt M., Finn T., Descamps J., Horiuchi Y., Sesardic D., Stickings P., Johnson N.W., Lipscomb E., Allen D. Non-animal replacement methods for human vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol. 2011;5:16–32. doi: 10.1016/j.provac.2011.10.002. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib0020] 4.Kulpa-Eddy J., Srinivas G., Halder M., Hill R., Brown K., Roth J., Draayer H., Galvin J., Claassen I., Gifford G., Woodland R., Doelling V., Jones B., Stokes W.S. Non-animal replacement methods for veterinary vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol. 2011;5:60–83. doi: 10.1016/j.provac.2011.10.005. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib0025] 5.Casey W., Schmitt M., McFarland R., Isbrucker R., Levis R., Arciniega J., Descamps J., Finn T., Hendriksen C., Horiuchi Y., Keller J., Kojima H., Sesardic D., Stickings P., Johnson N.W., Lipscomb E., Allen D. Improving animal welfare and reducing and refining animal use for human vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol. 2011;5:33–46. doi: 10.1016/j.provac.2011.10.002. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib0030] 6.Stokes W.S., Brown K., Kulpa-Eddy J., Srinivas G., Halder M., Draayer H., Galvin J., Claassen I., Gifford G., Woodland R., Doelling V., Jones B. Improving animal welfare and reducing animal use for veterinary vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol. 2011;5:84–105. doi: 10.1016/j.provac.2011.10.005. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib0035] 7.Isbrucker R., Levis R., Casey W., McFarland R., Schmitt M., Arciniega J., Descamps J., Finn T., Hendriksen C., Horiuchi Y., Keller J., Kojima H., Sesardic D., Stickings P., Johnson N.W., Allen D. Alternative methods and strategies to reduce, refine, and replace animal use for human vaccine post-licensing safety testing: state of the science and future directions. Proc Vaccinol. 2011;5:47–59. doi: 10.1016/j.provac.2011.10.002. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib0040] 8.Kulpa-Eddy J., Srinivas G., Halder M., Hill R., Brown K., Draayer H., Galvin J., Claassen I., Gifford G., Woodland R., Doelling V., Jones B., Stokes W.S. Alternative methods and strategies to reduce, refine, and replace animal use for veterinary vaccine post-licensing safety testing: state of the science and future directions. Proc Vaccinol. 2011;5:106–119. doi: 10.1016/j.provac.2011.10.005. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib0045] 9.Roth J. Veterinary vaccines and their importance to animal health and public health. Proc Vaccinol. 2011;5:127–136. doi: 10.1016/j.provac.2011.10.009. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib0050] 10.Schuchat A. Human vaccines and their importance to public health. Proc Vaccinol. 2011;5:120–126. doi: 10.1016/j.provac.2011.10.009. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib0055] 11.Finn T. U. S. FDA Requirements for human vaccine safety and potency testing. Proc Vaccinol. 2011;5:137–140. doi: 10.1016/j.provac.2011.10.002. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib0060] 12.Hill R.E. USDA requirements for veterinary vaccine safety and potency testing. Proc Vaccinol. 2011;5:141–145. [Google Scholar]

[bib0065] 13.Isbrucker R., Sontakke S., Smith D. Health Canada's human vaccine lot release program: impact on the 3Rs. Proc Vaccinol. 2011;5:147–150. [Google Scholar]

[bib0070] 14.Woodland R. European regulatory requirements for veterinary vaccine safety and potency testing and recent progress toward reducing animal use. Proc Vaccinol. 2011;5:151–155. [Google Scholar]

[bib0075] 15.Horiuchi Y., Ochiai M., Kataoka M., Yamamoto A., Yuen C.-T., Asokanathan C., Corbel M., Kurata T., Xing D. Strategic approaches for developing alternative tests for safety and potency of vaccines. Proc Vaccinol. 2011;5:156–163. [Google Scholar]

[bib0080] 16.Shin J., Lei D., Conrad C., Knezevic I., Wood D. International Regulatory Requirements for Vaccine Safety and Potency Testing: A WHO perspective. Proc Vaccinol. 2011;5:164–170. [Google Scholar]

[bib0085] 17.Draayer H. Overview of currently approved veterinary vaccine potency testing methods and methods in development that do not require animal use. Proc Vaccinol. 2011;5:171–174. [Google Scholar]

[bib0090] 18.Claassen I. Case study of development, validation, and acceptance of a non-animal method for assessing veterinary vaccine potency. Proc Vaccinol. 2011;5:175–183. [Google Scholar]

[bib0095] 19.Levis R. Overview of the current status of human vaccine potency testing methods that replace animals. Presented at: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions. NICEAM. Bethesda, MD. September 2010. Available at: http://iccvam.niehs.nih.gov/meetings/BiologicsWksp-2010/BiologicsWksp-present.htm.

[bib0100] 20.Descamps J. A Case study of development, validation, and acceptance of a non-animal method for assessing human vaccine potency. Proc Vaccinol. 2011;5:184–191. [Google Scholar]

[bib0105] 21.Keller J.E. Overview of currently approved serological methods with a focus on diphtheria and tetanus toxoid potency testing. Proc Vaccinol. 2011;5:192–199. [Google Scholar]

[bib0110] 22.Srinivas G. Refinement alternatives for veterinary vaccine potency testing: overview of currently approved serological methods. Presented at: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions. NICEAM. Bethesda, MD. September 2010. Available at: http://iccvam.niehs.nih.gov/meetings/BiologicsWksp-2010/BiologicsWksp-present.htm.

[bib0115] 23.Stickings P., Rigsby P., Coombes L., Hockley J., Tierney R., Sesardic D. Animal refinement and reduction: alternative approaches for potency testing of diphtheria and tetanus vaccines. Proc Vaccinol. 2011;5:200–212. [Google Scholar]

[bib0120] 24.Arciniega J.L., Domínguez-Castillo R.I. Development and validation of serological methods for human vaccine potency testing: case study of an anthrax vaccine. Proc Vaccinol. 2011;5:213–220. [Google Scholar]

[bib0125] 25.Hendriksen C.F.M. Humane endpoints in vaccine potency testing. Proc Vaccinol. 2011;5:221–226. [Google Scholar]

[bib0130] 26.Kulpa-Eddy J., Srinivas G. Approaches to reducing animal numbers in vaccine potency testing. Proc Vaccinol. 2011;5:227–231. doi: 10.1016/j.provac.2011.10.005. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib0135] 27.Kulpa-Eddy J., Dusek D. Application of the consistency approach in the United States to reduce animal use in vaccine potency testing. Proc Vaccinol. 2011;5:232–235. [Google Scholar]

[bib0140] 28.Gifford G., Agrawal P., Hutchings D., Yarosh O. Veterinary vaccine post-licensing safety testing: overview of current regulatory requirements and accepted alternatives. Proc Vaccinol. 2011;5:236–247. [Google Scholar]

[bib0145] 29.Arciniega J.L., Corvette L., Hsu H., Lynn F., Romani T., Dobbelaer R. Target alternative vaccine safety testing strategies for Pertussis toxin. Proc Vaccinol. 2011;5:248–260. [Google Scholar]

[bib0150] 30.Rubin S.A. Toward replacement of the monkey neurovirulence test in vaccine safety testing. Proc Vaccinol. 2011;5:261–265. [Google Scholar]

[bib0155] 31.United States Public Law 430 of 1913 and Public Law 99-198 (1985 amendments to the Virus-Serum-Toxin Act); Title 21 U.S. Code, Chapter 5 §§ 151 et. seq.

[bib0160] 32.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.108. SAM 207: Supplemental Assay Method for Potency Testing Clostridium novyi Type B Alpha Antigen. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.

[bib0165] 33.European Pharmacopoeia. Monograph 01/2010:0362. Clostridium novyi (type B) vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2010.

[bib0170] 34.EDQM. Alternative potency testing and other possible related quality issues for veterinary clostridial vaccines. Pharmeuropa, 1997 Special Issue, Bio 97-1. Strasbourg, France: European Department for the Quality of Medicines.

[bib0175] 35.Hendriksen C., Spieser J.M., Akkermans A., Balls M., Bruckner L., Cussler K., Daas A., Descamps J., Dobbelaer R., Fentem J., Halder M., van der Kamp M., Lucken R., Milstien J., Sesardic D., Straughan D., Valadares A. Validation of alternative methods for the potency testing of vaccines: the report and recommendations of ECVAM workshop 31. ALTA. 1998;26:747–761. [PubMed] [Google Scholar]

[bib0180] 36.European Pharmacopoeia. Monograph 01/2008:0364. Clostridium septicum vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.

[bib0185] 37.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.111. SAM 201: Supplemental Assay Method for Potency Testing of Clostridium perfringens Type C Beta Antigen. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.

[bib0190] 38.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.112. SAM 203: Supplemental Assay Method for Potency Testing of Clostridium perfringens Type D Epsilon Antigen. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.

[bib0195] 39.European Pharmacopoeia. Monograph 01/2008:0363. Clostridium perfringens vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.

[bib0200] 40.Rosskopf-Streicher U., Johannes S., Wilhelm M., Cussler K. Quality control of inactivated erysipelas vaccines: results of an international collaborative study to establish a new regulatory test. Vaccine. 2001;19:1477–1483. doi: 10.1016/s0264-410x(00)00346-7. [DOI] [PubMed] [Google Scholar]

[bib0205] 41.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.109. SAM 212: Supplemental Assay Method for Potency Testing of Clostridium sordellii Antigen. 2010.

[bib0210] 42.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.107. SAM 209: Supplemental Assay Method for Potency Testing Products Containing Clostridium haemolyticum Antigen. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.

[bib0215] 43.United States Department of Agriculture, Center for Veterinary Biologics, SAM 206: Supplemental Assay Method for Potency Testing Tetanus Antitoxins. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.

[bib0220] 44.United States Department of Agriculture, Center for Veterinary Biologics, SAM 217: Supplemental Assay Method for Potency Testing Tetanus Toxoid by ELISA. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.

[bib0225] 45.European Pharmacopoeia. Monograph 01/2008:0697. Tetanus Vaccine for Veterinary Use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.

[bib0230] 46.Council of Europe. 2.7.8 Assay of Tetanus vaccine (adsorbed). European Pharmacopoeia. 1996. Strasbourg, France: Council of Europe.

[bib0235] 47.Hendriksen C., Woltjes J., Akkermans A.M., van der Gun J.W., Marsman F.R., Verschure M.H., Veldman K. Interlaboratory validation of the in vitro serological assay systems to assess the potency of tetanus toxoid in vaccines for veterinary use. Biologicals. 1994;22:257–268. doi: 10.1006/biol.1994.1037. [DOI] [PubMed] [Google Scholar]

[bib0240] 48.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.103. SAM 625: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar canicola Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.

[bib0245] 49.European Pharmacopoeia. Monograph 01/2008:0447. Canine Leptospirosis vaccine (inactivated). 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.

[bib0250] 50.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products, Part 113 – Standard Requirements, Section 113.105. Leptospira Hardjo Bacterin. http://www.access.gpo.gov/nara/cfr/waisidx_09/9cfr113_09.html.

[bib0255] 51.European Pharmacopoeia. Monograph 01/2008:1939. Bovine leptospirosis vaccine (inactivated). 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.

[bib0260] 52.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.209. SAM 308: Supplemental Assay Method for Potency Testing of Inactivated Rabies Vaccines in Mice Using the National Institutes of Health Test. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.

[bib0265] 53.European Pharmacopoeia. Monograph XXXX: 0451 – Rabies vaccine (inactivated) for veterinary use. Pharmeuropa 2011;13:128-131.

[bib0270] 54.Cliquet F., Aubert M., Sange L. Development of a florescent antibody virus neutralization test (FAVN test) for the quantitation of rabies-neutralising antibody. Journal of Immunological Methods. 1998;212:79–87. doi: 10.1016/s0022-1759(97)00212-3. [DOI] [PubMed] [Google Scholar]

[bib0275] 55.Kramer B., Schildger H., Behrensdorf-Nicol H.A., Hanschmann K.M., Duchow K. The rapid fluorescent focus inhibition test is a suitable method for batch potency testing of inactivated rabies vaccines. Biologicals. 2009;37(2):119–126. doi: 10.1016/j.biologicals.2009.01.001. [DOI] [PubMed] [Google Scholar]

[bib0280] 56.Kramer B., Bruckner L., Daas A., Milne C. Collaborative study for validation of a serological potency assay for rabies vaccine (inactivated) for veterinary use. Pharmeuropa Bio. 2010:37–55. [PubMed] [Google Scholar]

[bib0285] 57.Nagarajan T., Reddy G.S., Mohana Subramanian B., Rajalakshmi S., Thiagarajan D., Tordo N., Jallet C., Srinivasan V.A. A simple immuno-capture ELISA to estimate rabies viral glycoprotein antigen in vaccine manufacture. Biologicals. 2006;34:21–27. doi: 10.1016/j.biologicals.2005.07.004. [DOI] [PubMed] [Google Scholar]

[bib0290] 58.Golde W.T., Pacheco J.M., Duque H., Doel T., Penford B., Ferman G.S., Gregg D.R., Rodriguez L.L. Vaccination against foot and mouth disease virus confers complete clinical protection in 7 days and partial protection in 4 days: Use in emergency outbreak response. Vaccine. 2005;23:5775–5782. doi: 10.1016/j.vaccine.2005.07.043. [DOI] [PubMed] [Google Scholar]

[bib0295] 59.Rodriguez L.L., Grubman M.J. Foot and mouth disease virus vaccines. Vaccine. 2009;27:D90–D94. doi: 10.1016/j.vaccine.2009.08.039. [DOI] [PubMed] [Google Scholar]

[bib0300] 60.Hendriksen C., Replacement reduction and refinement alternatives to animal use in vaccine potency measurement. Expert Rev Vaccines. 2008;8(3):313–322. doi: 10.1586/14760584.8.3.313. [DOI] [PubMed] [Google Scholar]

[bib0305] 61.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.67. SAM 612: Supplemental Assay Method for Bacterial Plate Count of Erysipelothrix rhusiopathiae Vaccines. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.

[bib0310] 62.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.68. SAM 905: Supplemental Assay Method for Test for Potency of Live Avirulent Pasteurella haemolytica Vaccine. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_900_series.shtml.

[bib0315] 63.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.71. SAM 319: Supplemental Assay Method for Titration of Chlamydophila felis (formerly Feline Chlamydia psittaci) in Embryonated Chicken Eggs. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.

[bib0320] 64.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.314. SAM 306: Supplemental Assay Method for the Titration of Feline Calicivirus in Cell Culture. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.

[bib0325] 65.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.315. SAM 307: Supplemental Assay Method for the Titration of Feline Rhinotracheitis Virus in Cell Culture. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.

[bib0330] 66.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.330. SAM 406: Supplemental Assay Method for Titration of Monovalent, Cell Associated Marek's Disease Vaccines of Serotypes 1, 2 or 3. 2005. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_400_series.shtml.

[bib0335] 67.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 114: Supplemental Assay Method for Titration of Porcine Transmissible Gastroenteritis Virus. 2011. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_100_series.shtml.

[bib0340] 68.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 121: Supplemental Assay Method for Titration of Porcine Rotovirus In Modified-Live Vaccines. 2005. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_100_series.shtml.

[bib0345] 69.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.305. SAM 304: Supplemental Assay Method for Titration of Infectious Canine Hepatitis Virus in Primary Canine Kidney Cell Culture. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.

[bib0350] 70.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 317: Supplemental Assay Method for Titration of Canine Adenovirus in Canine Kidney Cell Culture. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.

[bib0355] 71.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.331. SAM 408: Supplemental Assay Method for Titrating Tissue Culture Adapted Vaccine Strains of Infectious Bursal Disease Virus. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_400_series.shtml.

[bib0360] 72.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.304. SAM 305: Supplemental Assay Method for Titration of Feline Panleukopenia Virus in Cell Culture. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.

[bib0365] 73.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.307. SAM 316: Supplemental Assay Method for Titration of Canine Parvovirus in Cell Culture. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.

[bib0370] 74.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.302. SAM 303: Supplemental Assay Method for the Titration of Distemper Virus in Embryonated Chicken Eggs. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.

[bib0375] 75.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 320: Supplemental Assay Method for Titration of Chlamydophilia felis (formerly Feline Chlamydia psittaci) in Embryonated Chicken Eggs. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.

[bib0380] 76.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 411: Supplemental Assay Method for the Titration of Newcastle Disease-Infectious Bronchitis Vaccine in Chicken Embryos. 2011. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_400_series.shtml.

[bib0385] 77.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.301. Ovine Ecthyma Vaccine.

[bib0390] 78.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.119. SAM 613: Supplemental Assay Method for In vitro Potency Testing of Erysipelothrix rhusiopathiae Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.

[bib0395] 79.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 620-623: Supplemental Assay Method for Potency Testing Enterotoxigenic (K99, K 88, 987P, F41 Pilus) Escherichia coli Bacterins. 2009.http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.

[bib0400] 80.Johannes S., Hartinger J., Hendriksen C.F.M., Morton D.B., Cussler K. Humane endpoints in the efficacy testing of swine erysipelas vaccines. ALTEX. 2003;20:11–15. [PubMed] [Google Scholar]

[bib0405] 81.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.101. SAM 624: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar pomona Bacterins. 2009.http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.

[bib0410] 82.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.104. SAM 626: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar grippotyphosa Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.

[bib0415] 83.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.102. SAM 627: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar icterohaemorrhagiae Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.

[bib0420] 84.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 120: Supplemental Assay Method for the in vitro Potency Assay of Bovine Respiratory Viruses in Killed Vaccines. 1991. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_100_series.shtml.

[bib0425] 85.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 321: Supplemental Assay Method for Quantitating the GP70 Antigen of Feline Leukemia Virus in Veterinary Vaccines. 2007 http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.

[bib0430] 86.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 322: Supplemental Assay Method for Determination of the Specific Viral Antigen Content in Inactivated Canine Coronavirus Vaccines. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.

[bib0435] 87.Maas R.A., de Winter M.P.M., Venema S., Oei H.L., Claassen I.J.T.M. Antigen quantification as in vitro alternative for potency testing of inactivation viral poultry vaccines. Vet Quart. 2000;22:223–227. doi: 10.1080/01652176.2000.9695063. [DOI] [PubMed] [Google Scholar]

[bib0440] 88.Claassen I., Maas R., Oei H., Daas A., Milne C. Validation study to evaluate the reproducibility of a candidate in vitro potency assay of Newcastle disease vaccines and to establish the suitability of a candidate biological reference preparation. Pharmeuropa Bio. 2004;1:1–15. [PubMed] [Google Scholar]

[bib0445] 89.Liljebjelke K.A., King D.J., Kapczynski D.R. Determination of minimum hemagglutinin units in an inactivated Newcastle disease virus vaccine for clinical protection of chickens from exotic Newcastle disease virus challenge. Avian Diseases. 2008;52:260–268. doi: 10.1637/8154-101907-Reg.1. [DOI] [PubMed] [Google Scholar]

[bib0450] 90.Maas R.A., Komen M., van Diepen M., Oei H.L., Claassen I.J.T.M. Correlation of haemagglutinin-neuraminidase and fusion protein content with protective antibody response after immunisation with inactivated Newcastle disease vaccines. Vaccine. 2003;21(23):3136–3141. doi: 10.1016/s0264-410x(03)00249-4. [DOI] [PubMed] [Google Scholar]

[bib0455] 91.Claassen I., Maas R., Oei H., Daas A., Milne C. Feasibility study to evaluate the correlation between results of a candidate in vitro assay and established in vivo assays for potency determination of Newcastle disease vaccines. Pharmeuropa Biol. 2003;1:53–65. [PubMed] [Google Scholar]

[bib0460] 92.Kross I. Redhead K. Perspectives from industry: development of alternative test for quality control testing of veterinary vaccines. EDQM Proceedings; Alternatives to Animal Testing: New Approaches in the Development and Control of Biologicals; Dubrovnik, Croatia. 2008.

[bib0465] 93.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.65. SAM 600: Supplemental Assay Method for Purity, Potency and Dissociation of Brucella abortus Vaccine, Strain l9. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.

[bib0470] 94.European Pharmacopoeia. Monograph 01/2008:0589. Marek's disease vaccine (live). 7th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2010.

[bib0475] 95.European Pharmacopoeia. Monograph 01/2008:0587. Avian infectious bursal disease vaccine (live). 7th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2010.

[bib0480] 96.Thornton D.H. Standard requirements for vaccines against infectious bursal disease. Dev Biol Stand. 1976;33:343–348. [PubMed] [Google Scholar]

[bib0485] 97.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.119. SAM 611: Supplemental Assay Method for Potency Testing of Erysipelas Bacterins in Mice. 2008 http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.

[bib0490] 98.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.101. SAM 608: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar pomona Bacterins. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.

[bib0495] 99.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.103. SAM 609: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar canicola Bacterins. 2008 http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.

[bib0500] 100.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.104. SAM 617: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar grippotyphosa Bacterins. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.

[bib0505] 101.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.102. SAM 610: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar icterohaemorrhagiae Bacterins. 2008 http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.

[bib0510] 102.United States Department of Agriculture, Center for Veterinary Biologics, Veterinary Services Memorandum 800.104. In Vitro Serial Release Potency Test for Completed Product Containing Clostridium chauvoei. 2003. http://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo_800_104.pdf.

[bib0515] 103.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 220. Not available.

[bib0520] 104.European Pharmacopoeia. Monograph 01/2008:0361. Clostridium chauvoei Vaccine for Veterinary Use. 5th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.

[bib0525] 105.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.216. Bovine Rhinotracheitis, Killed Virus. http://edocket.access.gpo.gov/cfr_2003/9cfr113.216.htm.

[bib0530] 106.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.115. Staphylococcus Aureus Bacterin-Toxoid. 2002. http://edocket.access.gpo.gov/cfr_2002/janqtr/9cfr113.115.htm.

[bib0535] 109.Hendriksen C. Three Rs achievements in vaccinology. AATEX Special Issue. 2007;14:575–579. [Google Scholar]

[bib0540] 110.Jagt H.J.M., Bekkers M.L.E., Bommel S.A.J.T., Marel P., Schrier C.C. The influence of the inactivating agent on the antigen content of inactivated Newcastle disease vaccines assessed by the in vitro potency test. Biologicals. 2010;38:128–134. doi: 10.1016/j.biologicals.2009.07.006. [DOI] [PubMed] [Google Scholar]

[bib0545] 111.United States Department of Agriculture, Center for Veterinary Biologics, Veterinary Services Memorandum 800.112. Guidelines for Validation of In Vitro Potency Assays. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo_800_112.pdf.

[bib0550] 112.Barth R., Diderrich G., Weinmann E. NIH test, a problematic method for testing potency of inactivated rabies vaccine. Vaccine. 1988;6:369–377. doi: 10.1016/0264-410x(88)90185-5. [DOI] [PubMed] [Google Scholar]

[bib0555] 113.Wunderli P.S., Dreesen D.W., Miller T.J., Baer G.M. Effects of vaccine route and dosage on protection from rabies after intracerebral challenge in mice. Am J Vet Med. 2003;64:491–498. doi: 10.2460/ajvr.2003.64.491. [DOI] [PubMed] [Google Scholar]

[bib0560] 114.Wunderli P.S., Dreesen D.W., Miller T.J., Baer G.M. The rabies peripheral challenge test: more accurate determination of vaccine potency. Vaccine. 2006;24:7115–7123. doi: 10.1016/j.vaccine.2006.06.078. [DOI] [PubMed] [Google Scholar]

[bib0565] 115.Smith JS, Yager PA, Baer GM. A rapid tissue culture test for determining rabies neutralising antibody. In: Meslin F-X, Kaplan MM, Hoprowski H, editors. Laboratory Techniques in Rabies. Geneva, Switzerland, World Trade Organization, 1996;4:354-357. [PubMed]

[bib0570] 116.Bruckner L., Cussler K., Halder M., Barrat J., Castle P., Duchow K., Gatewood D.M., Gibert R., Groen J., Knapp B., Levis R., Milne C., Parker S., Stünkel K., Visser N., Volkers P. Three Rs approaches in the quality control of inactivated rabies vaccines. The report and recommendations of ECVAM Workshop 48. ALTA. 2003;31:429–454. doi: 10.1177/026119290303100409. [DOI] [PubMed] [Google Scholar]

[bib0575] 117.Jennings M., Morton D., Charton E., Cooper J., Hendriksen C., Martin S., Pearce M., Price S., Redhead K., Reed N., Simmons H., Spencer S., Willingale H. Application of the Three Rs to challenge assays used in vaccine testing: Tenth report of the BVAAWF/FRAME/RSPCA/UFAW Joint Working Group on Refinement. Biologicals. 2010;38:684–695. doi: 10.1016/j.biologicals.2010.04.004. [DOI] [PubMed] [Google Scholar]

[bib0580] 118.Lyng J., Benzton M.W., Ferguson M., Fitzgerald E.A. Rabies vaccine standardization: international collaborative study for the characterization of the fifth international standard for rabies vaccine. Biologicals. 1992;20:301–313. doi: 10.1016/s1045-1056(05)80051-x. [DOI] [PubMed] [Google Scholar]

[bib0585] 119.European Pharmacopoeia. Monograph 04/2008:0216. Rabies Vaccine for Human Use Prepared in Cell Culture. 5th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.

[bib0590] 120.Metz B., Brunel F., Chamberlin C., van der Gun J., Halder M., Jiskoot W., Kersten G., van Opstal O., Petersen J.W., Ravetkar S.D., Redhead K., Schwanig M., Wilhelmsen E.S., Vann W.F., Hendriksen C. The potential of physiochemical and immunochemical assays to replace animal tests in the quality control of toxoid vaccines. The report and recommendations of ECVAM Workshop 61. ATLA. 2007;35:323–331. doi: 10.1177/026119290703500307. [DOI] [PubMed] [Google Scholar]

[bib0595] 121.Piersma S.J., Leenaars M., Guzylack-Piriou L., Summerfield A., Hendriksen C., McCullough K. An in vitro immune response model to determine tetanus toxoid antigen (vaccine) specific immunogenicity: selection of sensitive assay criteria. Vaccine. 2006;24:3076–3083. doi: 10.1016/j.vaccine.2006.01.061. [DOI] [PubMed] [Google Scholar]

[bib0600] 122.Barnett P.V., Carabin H. A review of emergency foot-and-mouth disease (FMD) vaccines. Vaccine. 2002;20:1505–1514. doi: 10.1016/s0264-410x(01)00503-5. [DOI] [PubMed] [Google Scholar]

[bib0605] 123.Grubman M.J. Development of novel strategies to control foot-and-mouth disease: Marker vaccines and antivirals. Biologicals. 2005;33:227–234. doi: 10.1016/j.biologicals.2005.08.009. [DOI] [PubMed] [Google Scholar]

[bib0610] 124.Rodriguez L.L., Grubman M.J. Foot and mouth disease virus vaccines. Vaccine. 2009;27:D90–D94. doi: 10.1016/j.vaccine.2009.08.039. [DOI] [PubMed] [Google Scholar]

[bib0615] 125.Paton D.J., Sumption K.J., Charleston B. Options for the control of foot-and-mouth disease: knowledge, capability and policy. Phil Trans R Soc B. 2009;364:2657–2667. doi: 10.1098/rstb.2009.0100. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib0620] 126.Li Z., Liu J. The current state of vaccines used in the field for foot and mouth disease virus in China. Expert Rev Vaccines. 2011;10:13–15. doi: 10.1586/erv.10.146. [DOI] [PubMed] [Google Scholar]

[bib0625] 127.Golde W.T., Pacheco J.M., Duque H., Doel T., Penford B., Ferman G.S., Gregg D.R., Rodriguez L.L. Vaccination against foot and mouth disease virus confers complete clinical protection in 7 days and partial protection in 4 days: Use in emergency outbreak response. Vaccine. 2005;23:5775–5782. doi: 10.1016/j.vaccine.2005.07.043. [DOI] [PubMed] [Google Scholar]

[bib0630] 128.Meeusen E.N., Walker J., Peters A., Pastoret P., Jungersen G. Current status of veterinary vaccines. Clinical Microbiology Reviews. 2007;20:489–510. doi: 10.1128/CMR.00005-07. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib0635] 129.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 406. Supplemental Assay Method for Titration of Monovalent, Cell Associated Marek's Disease Vaccines of Serotypes 1, 2, or 3. 2011. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_400_series.shtml.

[bib0640] 130.United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 408. Supplemental Assay Method for Titrating Tissue Culture Adapted Vaccine Strains of Infectious Bursal Disease Virus. 2005. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_400_series.shtml.

[bib0645] 131.Oei H., Maas R., Venema S., Kant A., Claassen I. Quantification of infectious Bursal Disease viral proteins 2 and 3 in inactivated vaccines as an indicator of serological responses and as a measure of potency. Avian Pathol. 2004;33(2):126–132. doi: 10.1080/03079450310001652121. [DOI] [PubMed] [Google Scholar]

[bib0650] 132.Reitan L.J., Secombes C.J. In vitro methods for vaccine evaluation. Dev Biol Stand. 1997;90:293–301. [PubMed] [Google Scholar]

[bib0655] 133.Shao Z. Aquaculture pharmaceuticals and biologicals: current perspectives and future possibilities. Advanced Drug Delivery Reviews. 2001;50:229–243. doi: 10.1016/s0169-409x(01)00159-4. [DOI] [PubMed] [Google Scholar]

[bib0660] 134.Anderson D.P. Adjuvants and immunostimulants for enhancing vaccine potency in fish. Salmon Bay Biologicals. 1997;90:257–265. [PubMed] [Google Scholar]

[bib0665] 135.United States Department of Agriculture, Center for Veterinary Biologics, Veterinary Services Memorandum 800.90. Guidelines for Veterinary Biological Relative Potency Assays and Reference Preparations Based on ELISA Antigen Quantification. 1998.http://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo_800_90.pdf.

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Non-animal replacement methods for veterinary vaccine potency testing: state of the science and future directions

Jodie Kulpa-Eddy

Geetha Srinivas

Marlies Halder

Richard Hill

Karen Brown

James Roth

Hans Draayer

Jeffrey Galvin

Ivo Claassen

Glen Gifford

Ralph Woodland

Vivian Doelling

Brett Jones

William S Stokes

Abstract

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PERMALINK

Non-animal replacement methods for veterinary vaccine potency testing: state of the science and future directions

Jodie Kulpa-Eddy

Geetha Srinivas

Marlies Halder

Richard Hill

Karen Brown

James Roth

Hans Draayer

Jeffrey Galvin

Ivo Claassen

Glen Gifford

Ralph Woodland

Vivian Doelling

Brett Jones

William S Stokes

Abstract

References

ACTIONS

PERMALINK

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