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| Webinar: Navigating Regulatory Challenges For Cell And Gene Products In 2024 And Beyond | A multidiscipline panel of experts will discuss the importance of ancillary and starting materials management control strategies for CGT product development, recent FDA regulatory developments for expedited regulatory pathways for cell and gene therapy products (specifically the recent regulatory initiatives for improving efficiency of accelerated approval pathway), and regulatory considerations crucial for using companion diagnostics in CGT. Click here to learn more. |
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By Brent Morse and Nate Manley, Dark Horse Consulting | On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and final version and what questions remain for the industry and scientific community to help resolve. |
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| 3 Strategies For Optimal Oversight Of Your Outsourcing Partner | Article | By Stephanie Gaulding, Pharmatech Associates - A USP Company | Building strong relationships with CDMOs and CROs relies on a solid outsourcing framework. Review three key areas that should be built into your outsourcing framework and agreements. |
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| 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. |
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