03.08.24 -- Cell & Gene Best Of February

Stem cells are the backbone of many allogeneic therapies and where they come from affects development and supply chain logistics, particularly cryopreservation. What temperatures are ideal to maintain product potency? How do you build a reliable cold chain? How do you work with existing infrastructure to allow for an “off-the-shelf” therapy? Don’t miss the next Cell & Gene Live digital event! Registration is free thanks to the support of Charter Medical and Bio-Techne.

The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance. The public comment period ends March 27, 2024.

This author breaks down, summarizes, and shares detailed insight on the recent FDA Draft Guidance that addresses Rare Diseases: Considerations for the Development of Drugs and Biological Products.

The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on Jan. 29, 2024. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.

Where do the regulatory perspectives align and diverge? Examine the similarities and differences between how the FDA and the European Medicines Agency approach cell and gene therapies.

Explore regulatory expectations and guidelines around AAV gene therapy, tips for meeting regulatory guidelines, gene-modified cell therapy and more, with eight experts in the cell and gene therapy field.

Learn how leveraging the expertise of an experienced partner can help ease challenges relating to regulatory approval and patient access to chimeric antigen receptor T cell (CAR T) therapies.