Cell-based bioassays are the primary tool for determining the biological activity of drugs, making them a critical, regulatory-required part of the testing repertoire. Bioassays show the potency of a product in comparison to a reference standard and quantify its ability to produce a certain biological effect.
Companies must generate this information on drug substances during stability and forced degradation studies and to support release testing of the finished product.
Bioassays can be a particularly challenging part of the drug development process as they must be performed in line with regulatory guidelines, including ICH Q2 (R1) and ICH Q6B. At RSSL, we work in partnership with our clients to meet these stringent standards by conducting bioassays in GMP-compliant facilities, staffed by highly trained and experienced technical teams.
Our analytical services can be tailored to the needs of our partners to create bespoke services in line with the development goals of each project. We employ techniques such as ELISA, real-time PCR and in vitro cell-based methods to reveal complicated responses to biological activity and capture the required data, whether it is related to protein and gene expression or cell growth.
Through these bespoke services, we can determine the potency of monoclonal antibodies, peptides, growth factors and cytokines, as well as confirm the bioactivity of products. These results support you in understanding the active biological molecule, in compliance with ICH Q6B guidelines, and help you characterise its physico- and immunochemical properties, impurities and biological activity.
Our cell-based bioassay service is part of a complete package of required biopharmaceutical tests, so that you can rely on us to be a single trusted vendor for all of your vital assessments. For further information or to discuss your needs please contact us.