All Chemistry, manufacturing and controls (CMC) articles
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EditorialAdvanced therapies: A maturing regulatory framework
This issue looks at CMC requirements, recent therapeutic innovations in the oncology field, and the complex interconnection between ATMPs and in vitro diagnostic medical devices.
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JournalGene Therapy Medicinal Products: An examination of regulatory CMC requirements
This article explores the CMC requirements for GTMPs to help ensure high quality and safe products are brought to market.
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JournalConsiderations in the development of allogenic and autologous cell therapies
Autologous cell therapy involves the use of a patient’s own cells which are harvested, modified or expanded ex vivo and then reintroduced into the patient. Allogeneic therapies use cells from a donor modified or expanded ex vivo and then administered to the patient.
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PodcastsRegRapPod − February 2024
Vol.21 #2: In February 2024’s RegRapPod, host Alan Booth talks to Issue Editors Dejan Brkic and Esteban Herrero-Martinez about medtech.
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Podcasts
RegRapPod − January 2024
Vol.21 #1: In January 2024’s RegRapPod, host Alan Booth talks to Issue Editors Julie Warner and Ash Ramzan about biologics.
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JournalCell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies
Cell and gene therapy (CGT) products represent a frontier in modern medicine, offering precision treatments. Yet their development is affected by multifaceted challenges including chemistry, manufacturing, and controls (CMC). This article provides a comprehensive exploration of the complexities involved in CMC development and considers its role in establishing quality, safety ...
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