Cell-based bioassays
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.
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. We also have flow cytometry and fluroescent microscopy capabilities which we use to support cell bioassay work and can use for ID analytical methods.
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.
A leading innovator in the development and validation of bio-activity for biopharmaceuticals and anticancer drugs. Our comprehensive expertise encompasses a wide range of assays designed to evaluate and ensure the efficacy of these critical compounds:
We also provide tailor-made mode of action cell bioassays, developed in collaboration with our cell engineering partners to create the specific reporter cell line, further underlining our commitment to delivering comprehensive solutions in the realm of bio-activity assessment.
Watch Alistair Michel as he talks through a case study highlighting the use of custom T-cell line from Promega 2023
