Potency assays are essential for product quality and patient safety. These tests enable a direct measurement of a biologic's functional activity, verifying that the therapy works as intended. Potency ...
Tumor necrosis factor alpha (TNFα) is a potent cytokine involved in immune surveillance and function. Dysregulated TNFα levels have been implicated in chronic diseases such as rheumatoid arthritis, ...
Several pharmaceutical industry groups and companies have criticized the US Food and Drug Administration’s (FDA) recent guidance on potency assurance strategies for cell and gene therapies (CGTs) ...
Center for Biologics Evaluation and Research (CBER) has issued a guidance to assist sponsors in assessing potency assays for ...
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