Cell Based Potency & Bioassays
BioOutsource is the industry leader in the biological analysis of biologic drugs. We have extensive experience in the development, optimization and validation of cell based bioassays to assess the myriad of functions that can be mediated by a monoclonal antibody. Our comprehensive expertise is not limited to simple measurements of primary potency but enable full characterization of the different biological activities of your molecule including recruitment of effector functions and induction or inhibition of a variety of secondary and tertiary activities as well as evaluation of antibody internalization. Combined with our full range of binding assays, we can provide the total solution to biological characterization of your molecule.
Cell-based potency assays or bioassays represent the only analytical method that allows a true measurement of the biological activity of a monoclonal antibody. In vitro bioassays provide critical information through the drug development process starting at candidate selection and early phase product characterization through to the final product.
Cell-based potency assays are considered to be amongst the most complex and problematic of all analytical methods and choosing the right partner for the development and operation of bioassays is a critical choice. BioOutsource has established itself at the forefront of bioassay and potency assay contract testing worldwide and our scientists have a wealth of experience across a wide range of products and bioassay methods and can provide expert support and advice on the technical and regulatory aspects at all phases of drug development providing cost effective solutions.
BioOutsource Bioassay Services:
With an extensive choice of assay endpoints, our bioassay experts can assess a wide range of mechanisms of action including:
- Cell Proliferation
- Cell Death
- Cell Signaling
- Receptor Binding
- Receptor Activation
- Ligand Binding
- Calcium Flux
The bioassays offered at BioOutsource can be performed using traditional assay endpoints of absorbance (OD), Flourescence, Luminescence and FRET. We also offer the more complex endpoints detailed below that require additional development:
- Electochemiluminesence (MSD)
- Flow Cytometry (iQue Screener PLUS)
Contact us to discuss your cell based potency and bioassays needs.