Bioassay and cGMP Potency Testing
Bioassays are essential for the development of new drugs. In particular, per regulatory requirement, they are performed to determine the biological activity or potency of the product, a critical quality attribute according to ICH Q6B.
Due to their complex nature, bioassays are one of the most challenging assays to perform. Therefore, consistent assay performance requires a controlled environment, skilled analysts with a thorough understanding of cell physiology and a well-developed and characterized method.
Eurofins Lancaster Laboratories offers extensive experience in all aspects of bioassay development, validation, method transfer and long-term assay maintenance. We provide a dedicated turnkey service for all your bioassay needs. Together with our partner lab, BSL BIOSERVICE, we have the capabilities to design and execute customized binding assays, cellular in vitro bioassays, as well as non-cell-based in vivo bioassays.
Our unmatched expertise and proven track record for cGMP potency assay testing ensures successful and timely completion of your testing program.
Why Choose Eurofins Lancaster Laboratories?
- We have a success rate of greater than 95% on potency assay transfers.
- We achieve RSDs of +20% or better for binding assays and +25% or better on most cell-based assays.
- We have more experienced Ph.D.s than any other contract laboratory, including Ph.D. scientists dedicated to troubleshooting problematic assays and developing new assay platforms and methodologies.
- We perform approximately 80 potency development and transfer projects per year.
Our validation strategies are based on a sponsor’s requirements, as well as international regulatory guidelines and recommendations, such as ICH, US-FDA, ISO, EMA and USP/EP. Our development, optimization (using Design of Experiments), validation and performance of bioassays and potency assays are US FDA approved and are conducted according to GMP regulations.
Potency Assay Experience
Our scientists have a wealth of experience performing a variety of binding and cell-based potency assays to support development, licensing and commercial release of various biopharmaceutical products. We have established and validated various sponsor-specific assays, pharmacopeia methods, as well as generic biosimilar methods, including Erythropoietin, Filgrastim, Interferon, Etanercept, Adalimumab, Golimumab, Bevacizumab, Rituximab and Trastuzumab.
- Therapeutic antibodies (monoclonal Ab, Bi-specific Ab, Fab, antibody drug conjugate/immunoconjugate)
- Recombinant proteins (growth factors, cytokines, soluble receptors, Fc or other fusion proteins)
- Gene therapy products (viral and plasmid based)
- Binding assays (ELISA, HTRF, AlphaLISA, SPR)
- Cell based assays (cell proliferation assay, cytotoxicity assay (including ADCC and CDC), apoptosis assay, reporter gene assay, cellular binding assay, cell signaling assay (cAMP, phosphorylated protein), cell migration assay, virological assay (CPE, transduction with ELISA/qPCR end point)
- In vivo assay
- 3HTymidine incorporation
Request more information to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.