All Chemistry, manufacturing and controls (CMC) articles

Journal

Considerations in the development of allogenic and autologous cell therapies

2025-01-10T08:51:00Z

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.

Journal

Health Canada: Points to consider when preparing quality and new substance notification documentation for investigational medicinal products

2024-12-06T11:53:00Z

 

Editorial

Chemistry, manufacturing and controls: accelerating development and boosting innovation

2024-10-11T12:00:00Z

 

Journal

Breaking barriers: the future of CMC powered by AI

2024-10-11T10:24:00Z

 

Journal

Device submissions for combination products: a data-driven perspective

2024-04-03T12:00:00Z

 

Podcasts

RegRapPod − 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.

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.

Journal

Cell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies

2024-01-05T00:05:00Z

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 ...

Journal

January 2024