Biological therapeutics have extremely specific and potent effects. The working mechanism however can be strongly affected by small variations in these complex molecules. For this reason, the effective potency of the therapeutic, whether it is a protein, a vaccine or other molecule, needs to be demonstrated for each batch prior to its release. This is typically done in cell based assays, using reporter markers to verify that the batch induces the correct pathways.
Eurofins BioPharma Product Testing Netherlands can support you in developing novel potency assays, as well as in performing novel or existing potency assays to demonstrate the efficacy of your therapeutic compound.
What products should be tested:
- Protein based therapeutics
- Monoclonal antibodies
- Gene Therapy products
Some examples of assays we offer:
- Interferon potency assay
- EPO potency assay
- Viral Vaccine infectivity assay
- Monoclonal binding assay
- Cell death based assays
Why choose Eurofins BioPharma Product Testing Netherlands
Benefit from our long experience in cell based assays, going back more than two decades. Our cell line collection, technical expertise and customer focused solutions can aid you in getting your product to the market reliably and according to the highest quality standards.
Comprehensive Services to Support Biosimilars
Our comprehensive offering of testing services enables us to support all aspects of your biologics development project, including:
- Full GMP Stability and Release Testing
- Biochemical Characterization, meeting ICH guidelines (particularly ICH Q6B)
- cGMP Mammalian Cell Bank Manufacturing and Cell Line Characterization
- Viral Safety
- Lot Release for adventitious agents
- Molecular and Cell Biology
Contact us if you would like to know more.