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) and can also assess potential off-target binding to healthy cells and immune activation (immunotoxicity). 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 product and process-related 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, including both on-target and off-target immunotoxicity, prior to embarking on clinical trials.
The Epibase® in vitro assays use human peripheral blood mononuclear cells (PBMCs) and in some cases combined with other healthy human tissue cells providing researchers with an immune response that closely resembles that of a patient in the clinic. For the Epibase® in vitro assays, whole blood and leukopaks are collected at clinical sites adhering to ethically approved protocols.
- PBMCs isolated and cryopreserved within 8 hours of blood/leukopak 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)