Development of a Generic HCP ELISA for the Measurement of Impurities Derived from the HEK293 Expression System
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Contributing Authors:
Antonia Brendler*; Stefan Sommerschuh*; Pia Paarmann, PhD*
HEK293 (human embryonic kidney 293) cell lines offer a particularly beneficial expression system for the manufacturing of therapeutic recombinant proteinsor viral vectors1, 2. The ability to perform human-like posttranslational modifications of proteins and high transfection efficiencies make them an excellent choice for vaccine development or cell and gene therapy3, 4. In consistence with our multi-kit approach, we developed two kit types for the detection of HEK293-HCPs: Type SN and Type CL. The two kit types are based on either the supernatant (SN) or the cell lysate (CL) derived from HEK293 mock fermentation which served as antigen preparations for antibody development. Polyclonal antibodies were generated by immunization of rabbits followed by affinity purification using the respective HEK293-HCP mock material. The antigen samples and HCP antibodies were comprehensively characterized as part of this study.
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