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. The bioassays show the potency of a product in comparison to a reference standard and quantify its efficacy and ability to achieve a certain biological effect. Companies must generate this information on drug substances and products during stability and forced degradation studies, and to support release testing of the finished product.

Bioassays are a particularly challenging part of the drug development process and must be performed in line with guidelines including ICH Q2 (R1) and ICH Q6B if the results they generate are to be accepted by regulatory agencies. RSSL works in partnership with our clients to meet these stringent standards by performing bioassays in GMP-compliant facilities staffed by highly trained and experienced technical team.

A BESPOKE BIOASSAY SERVICE

We tailor our analytical services to the needs of our partners to create bespoke services aligned to the development goals of each project. In doing so, we use methods and techniques such as in vitro cells, ELISA and real-time PCR to reveal complicated responses to biological activity and capture data against the chosen endpoint, whether it is related to cell growth or protein or gene expression.

Through these bespoke service offerings, we will confirm the bioactivity of products and determine the potency of peptides, monoclonal antibodies, growth factors and cytokines. These results enable biopharmaceutical companies to understand the active biological molecule, in compliance with ICH Q6B guidelines, and characterise its physico- and immunochemical properties, impurities and biological activity.

RSSL provides the cell based bioassay service as part of a complete package of required biopharmaceutical tests, enabling partners to rely on a single trusted vendor for all their most important assessments. For further information or to discuss your needs please contact us.



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