Predicting immunogenicity of candidates promotes knowledge-based decisions for candidate selection
Lonza’s Epibase® in vitro platform evaluates the immunogenicity risk of biotherapeutic proteins by directly measuring the immune response induced by the protein in peripheral blood mononuclear cells (PBMCs). The Epibase® in vitro platform allows a direct comparison of immunogenicity risk for multiple biotherapeutic leads in a safe and cost effective manner. When combined with our proprietary Epibase® in silico tool, these cellular assays allow for a complete immunogenicity risk assessment of your lead candidates. In addition to screening lead candidates, the platform can also be used to assess the impact of a process change or production/purification impurities on the immunogenicity risk of your candidates. Understanding the immune response against your leads in a fully human system during early development will allow you to manage any potential safety and immunogenicity risks prior to embarking on clinical trials.
The Epibase® in vitro assays use human peripheral blood mononuclear cells (PBMCs) providing researchers with an immune response that closely resembles the response in a human. For the Epibase® in vitro assays, whole blood is collected at Phase I clinical sites adhering to ethically approved protocols.
- PBMCs isolated and cryopreserved within 8 hours of blood withdrawal
- Donors genotyped to a 4-digit level at HLA Class I and II loci
- Stringent quality control analysis, including cell viability, functionality and sub-population
Lonza routinely isolates PBMCs from healthy donors and has access to over 200,000 healthy donors at a number of Phase I clinical trial sites. Lonza also has the option to source specific disease patients or tailor the population by ethnicity, gender and age. This allows leads to be tested in a population representative of the disease and target patient population.
Epibase® in vitro Assays:
Designed for a Wide Range of Targets:
- Antibodies and antibody fragments
- Biotherapeutic proteins
- Enzyme replacement therapies
- Plant and bacterial proteins
- Viral vectors
- Synthetic peptides
Advantages of Epibase® in vitro Assays:
- Multi-parameter measurement of human primary immune cell activation by flow cytometry, FluoroSpot and Luminex® allows for a detailed characterization of the immune response
- High throughput processes capable of running large panels of samples
- Stringent quality control to guarantee assay consistency and traceability of each sample
- Consistent supply of diverse, high quality PBMC samples from healthy human donors
- PBMC can also be isolated from specific patient groups to characterize the immune response in the disease background (taking into account patient genetics, immune status and concomitant medication)