Long-Term Stability Requirements for Cell-Based Therapeutics
Long-Term Stability Requirements for Cell-Based Therapeutics Long-Term Stability Testing for Cell-Based Therapeutics: Regulatory Expectations and Practical Strategies Cell-based therapeutics—such as CAR-T cells, stem cell therapies, and engineered autologous or allogeneic products—represent a frontier in modern medicine. However, their inherent complexity and sensitivity to environmental conditions make long-term stability testing particularly challenging. These products are not…
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