Most biopharmaceuticals are produced in living cells through recombinant engineering, and then purified from the cells or their culture media using sophisticated protein purification techniques in a multistep downstream process. These processes have achieved great progress since the first biopharmaceuticals were approved for human use. As well as the need to monitor the product itself, the nature of these processes means that it is necessary to monitor any contaminants in the product and their removal through the purification steps. Contaminants could originate from the host cell proteins or they could be introduced during the subsequent purification steps.
Gyros assay project
Fleet developed an assay for measurement of viral capsid protein in cell culture media to support monitoring of bioprocesses. The assay was quickly optimised and performance verified, allowing simple transfer to the client's laboratory for routine use. The assay developed showed enhanced dynamic range compared to the ELISA kit previously used and allowed considerable savings in sample and reagent volumes as well as analyst time.