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. Author manuscript; available in PMC: 2015 Jun 25.
Published in final edited form as: Cancer Gene Ther. 2015 Feb 27;22(2):85–94. doi: 10.1038/cgt.2014.81

Table 2.

Example of Quality-control assays for clinical-grade SB plasmid

Testing Example assays Criteria
Purity Identity Restriction mapping and agarose gel Expected band size
Sequencing Sanger, high through put Confirm the original coding sequence
Concentration absorbance at 260nm 2.0 ± 0.2 mg mL−1
A260/A280 absorbance assay name 1.8 ± 0.2
Plasmid Form HPLC >90% supercoiled
Safety Sterility Test USP, no growth within 14 days No growth for 14 days
Bacterial endotoxin Kinetic LAL test <50 EU mg−1
E. coli host protein ELISA <0.3%
E. coli RNA HPLC <10%
Others Appearance Observation Clear, colorless, liquid

Abbreviations: E. coli, Escherichia coli; ELISA, enzyme-linked immunosorbent assay; HPLC, high-performance liquid chromatography; SB, Sleeping Beauty.