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Chemistry, Manufacturing and Controls (CMC) issues often relate to starting and ancillary materials, manufacturing processes, and process/ quality control.
Released By Cardinal Health
July 11, 2022
Cell and Gene Therapy: CMC Challenges and Mitigation Strategies Novel technologies, complex manufacturing and accelerated development timelines make CMC critical for CGT products. Read More >> Eliminating Endotoxins – Reagent Quality Testing for Cell and Gene Therapies The importance of reagent quality control, especially endotoxin testing, during CGT development and the selection of reagents and suppliers to ensure safety. Read More >> Cell & Gene Therapy Delivery Devices A Q&A with Cardinal Health’s Mathew Varkey, Supervisor, Regulatory Submissions Operations. Read More >> Earning RMAT Designation What developers need to know Read More >> An Introduction to Phase-Appropriate CGMP Considerations for Cell and Gene Therapy Readiness to begin GMP manufacturing is a decision point that requires careful consideration. Read More >>
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