FDA's Francis R.W. Godwin (CDER) and Kathleen Jones, PhD (CBER) detail a record pace of drug warning letters and the CGMP deficiencies most commonly cited in biologics facility inspections.
News|Articles|November 4, 2024
Best Practices, Strategies & Use of Novel Biological Responses for Robust Cell-Based Potency Assays (Executive Summary)
Author(s)Catalent
Cell-based assays (CBAs) are key tools for evaluating the potency of new biologic drugs. Catalent’s transcription-based bioassay simplifies and empowers the testing of new biologics.
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