Tips to Ensure Product Comparability in Gene Therapy
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Why is it important to study how manufacturing changes affect product quality?
Heidaran: Gene therapies are complex, and the product is largely defined by the process, which means minor changes could potentially cause major changes in quality and efficacy.
Development timelines are also quite compressed. Whereas you might have a 10- to 15-year development program for a small molecule or biologic, you can get some advanced therapies approved in around five years. There’s also quite a bit of process change involved because you’re starting with small-scale academic manufacturing and switching to an internal facility or CMO [contract manufacturing organization] for commercial production.
These credits have been accumulated over the course of the year from dust jackets,
Acknowledgments sections and copyright pages in works, cover reveal blog posts, and other sources on the internet. This year, Filers Martin Pyne and Karen B. also collected this information, and though we had a lot of overlap, their extra entries have greatly increased the information we are able to provide you. My profound thanks go to Martin and Karen for all of their hard work.
You can see the full combined spreadsheet of Editor and Artist credits here (I will be continuing to update this as I get more information).