New Raw Materials Cell Based Services target cell viability and cell potency assays

Andrew D. Schaefer, Manager; Aaron Miller, Scientific Group Leader; Analytical Method Development & Validation, Biopharmaceutical Raw Materials

Since the inception of the Eurofins Lancaster Laboratory’s Pharmaceutical Raw Materials service decades ago, the team has expanded its testing capabilities and grown to over 200 employees. The current service offering includes compendial and non-compendial QC release testing in chemistry and biochemistry disciplines, as well as, developing and establishing methods for cGMP use. With such a wide array of testing services already provided, the expansion to include cell-based assays for raw and ancillary materials is a continuation of Eurofins BPT’s commitment to meet our customers’ evolving needs.

Working in a new 1000 ft² BSL2 space, our scientists will handle various raw materials such as growth media, cell preservation solutions, cytokines and growth factors that are all utilized in the manufacture of Advanced Therapy Medicinal Products (ATMP). The focus for the group will be on developing cell-based assay methods specifically targeting cell viability and cell potency assays. The objective of cell viability testing is to ensure that the client’s material will not have an adverse effect (cytotoxicity) or ensure the material has sufficient positive effect such as nutrition, protection, etc. on their downstream product. The various cell potency assays evaluate the cytokine and growth factors’ effect in order to confirm that the client’s material is suitable.

A platform approach for cytotoxicity testing was created to streamline on-boarding new materials by reducing costs and overall timelines. The platform method is currently setup for testing using one of three cell lines: HEK-293, CHO or COS-1.

Please contact your Business Development representative for more information.