ADDITIONAL SPECIFICITY TESTING

Enzyme-linked immunosorbent assay (ELISA)

ELISA is used to confirm the specificity of the antibody product. When ELISA assay is part of the final inspection of a product, the result is reported in the CoA. Results may only be provided to the customer as a positive control for the antibody specificity. ELISA analysis is not part of the general quality assurance procedure, but may be included upon request.

Biacore®

Test results from Biacore measurements indicate binding capacity of the antibody by comparison to curve with relative number describing binding capacity. Test results are evaluated and approved by qualified staff. Biacore analysis is not part of the general quality assurance procedure, but may be included upon request.

Sodium dodecyl sulfate (SDS) Polyacrylamide gel electrophoresis (PAGE)

SDS PAGE separates proteins according to their electrophoretic mobility, reflecting their molecular weight (size of polypeptide). To define the molecular weight a standard is always run together with the sample. SDS PAGE is used to confirm the purity of the products. SDSPAGE is not part of the general quality assurance procedure, but may be included upon request.

Sixe exclusion chromatography (SEC)

SEC is used to separate the proteins in a solution according to size. SEC is used to determine the purity as well as to confirm the absence of alternative isoforms or degraded antibodies in end product. SEC analysis is not part of the general quality assurance procedure, but may be included upon request.