[White Paper] Accelerating Biosimilar & Biobetter Drug Development: Ready-to-Use, Cell-Based Assays for Potency and Lot Release Testing
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With the drug industry’s expanding emphasis on biologics, the need for robust cell-based assays has grown at all stages of development. Requirements for efficacy, quality, and potency testing often demand a complex set of bioassays and/or cell-based assays for new therapeutics or biosimilars. Developers of the latter have found this need for cell-based assays to be particularly challenging. Commercially available, ready-to-use cell-based assays provide a robust functional response from specific therapeutic targets. They can significantly shorten assay development time while facilitating adoption and greater reproducibility across multiple global sites. Examples discussed in this white paper include cell-based assays for bevacizumab (Avastin), insulin, glucagon-like peptide 1 (GLP1), growth hormone (GH), and anti-tumor necrosis factor alpha (anti-TNFα) antibodies. These case studies highlight how commercial tools can reduce assay development time, enabling a biologic developer to move quickly with the goal of getting to market or submission before their competitors.