At the end of 2018, BPI published its first eBook about mRNA drug products — and quite a lot has happened since then! Our initial report highlighted companies working on mRNA therapeutics for cystic fibrosis, heart disease, and cancer, as well as vaccines. The latter approach took off in 2020 with the advent of SARS-CoV-2 and the COVID-19 pandemic, and in a stunningly short time, the biopharmaceutical industry has learned much about manufacture, formulation, product design, and distribution of mRNA…
Author Archives: Cliff Schorr
Managing Cell-Based Potency Assays
Established at the forefront of current good manufacturing practice (cGMP) cell-based potency assay contract testing, Eurofins Lancaster Laboratories, Inc. provides assistance in all aspects of bioassay development, validation, method transfer, and long-term assay maintenance. Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity, and impurities — is necessary to establish the safety and efficacy profile of a given product (as per ICH Q6B guidelines). Cell culture–based potency assays…