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Regulatory Considerations For Cell and Gene Therapies

Chemistry, Manufacturing and Controls (CMC) issues often relate to starting and ancillary materials, manufacturing processes, and process/ quality control.

Released By Cardinal Health

Cell and Gene Therapy: CMC Challenges and Mitigation Strategies
Novel technologies, complex manufacturing and accelerated development timelines make CMC critical for CGT products.
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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.
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Cell & Gene Therapy Delivery Devices
A Q&A with Cardinal Health’s Mathew Varkey, Supervisor, Regulatory Submissions Operations.
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Earning RMAT Designation
What developers need to know
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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.
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