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 molecules, needs to be demonstrated for each batch prior to its release.
We provide both Binding Assays and Cell-based Assays to characterize biological activity.
Eurofins BioPharma Product Testing Netherlands can support you in performing novel or existing potency assays to demonstrate the efficacy of your therapeutic compound.
Some examples of assays we offer:
- Surface Plasmon Resonance
- Proliferation Assay
- Apoptosis Assay
- Cytotoxicity Assay, ADCC and CDC Assays
- Cellular binding Assay
- Viral Vaccine infectivity assay
What products should be tested:
- Protein based therapeutics
- Monoclonal antibodies
- Gene Therapy products
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.