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AUG 2023

Innate and Adaptive Immune Activity of Generic Biotherapeutic Products


Immune cell-based assays to demonstrate equivalence of generic biotherapeutic products to their respective reference listed drugs (RLDs) and to evaluate sameness of impurity profiles and associated immunogenicity risk between the generic and RLD products were developped. Our in vitro assays using human fresh PBMCs or whole blood (primary cells) for evaluating comparative immunogenicity risk is optimized for detecting both adaptive and innate immune activity. Various parameters including sensitivity and specificity of the assays were assesed to evaluate:

- drug product concentrations and excipient effects;

- cell viability and immuno-toxicity;

- quality control on cell preparations;

- standardized procedures for sampling, cells isolation and handling.

Fresh PBMC and Whole Blood Cytokine Release Assays to Evaluate the Risk of

Immunogenicty of Generic Biotherapeutic Products

Screenshot from 2023-08-01 15-29-23.png

Normalized Cytokine Response of PBMCs or whole blood from 11 healthy human donors treated with PBS as negative control (NC) and PHA/LPS/Zymosan as positive control for 24h. Supernatants were analyzed for the presence of 15 cytokines/chemokines multiplex panel using Luminex platform.

Shown are the stimulation index (fold) of TNFa and IL-6 responses obtained from PBMC (blue) and whole blood (red) of two donors (D4 and D5).

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