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. Author manuscript; available in PMC: 2010 Nov 23.
Published in final edited form as: Vaccine. 2009 Sep 26;27(50):7087–7095. doi: 10.1016/j.vaccine.2009.09.059

Table 3.

Release testing and specifications for EP-1043 bulk protein

Test Method Acceptance Criteria
Protein Concentration BCA assay ≥ 0.4 mg/mL
Identity SDS-PAGE/Western Blot ±38 kDa apparent MW protein detected by peptide specific antisera produce in rabbits
Purity SDS-PAGE/Scanning Densitometry Not less than 80% pure
Residual Host Cell Protein Assay Western Blot Not more than 5%
Endotoxin Limulus Amebocyte Lysate Less than 30 EU per mg of protein
DNA Content PCR Less than 100 pg DNA per highest clinical dose
Sterility 21 CFR 610.12 No bacterial or fungal growth observed
Viruses Co-cultivation, 3 cell types (MRC-5, Vero, BHK) No viral contamination observed
Mycoplasma/spiroplasma 21CFR 610.30 No mycoplasma or spiroplasma detected