Cell & Gene Collaborative Blog

  1. ARW's C&G+RNA Manufacturing Must-Reads (Pinocchio Edition!) 2/27/2023

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.

  2. ARW's C&G+RNA Manufacturing Must-Reads (I LOVE YOU, PIZZA Edition!) 2/9/2023

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.

  3. Cell & Gene Manufacturing Risk Vs. Benefit: How It's Reflected In Our FDA Interactions 2/7/2023

    Though many important topics of conversation were broached during the 2022 FDA CMC townhalls, there were two within which the industry is working to define how much is too much or not yet enough. In the following two parts of this article, I’ll briefly unpack some of the high-level best practices offered by the FDA to help you work your way towards “just right.”

  4. GMP Principles: The True Star Of Cell & Gene FDA Interactions 2/2/2023

    The questions posed to the FDA during both the cell and gene town halls indicate that we are trying to better define “phase appropriate” development and understand where our material/vendor selection and qualification need to be more diligent. Despite the murkiness of this topic in general, there were a few best practices I took away from the FDA’s recommendations.

  5. ARW's C&G+RNA Manufacturing Must-Reads (“Compliment” Your Spouse Edition!) 1/27/2023

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.

  6. Metaphorical mRNA: An Argument For (More) Creativity In RNA Therapeutics 1/25/2023

    In putting together my mRNA outlook presentation for November's 2022 AGC CDMO Summit, I realized there is one opportunity that should be top of mind for the RNA therapeutics industry in the years to come. We all, regardless of our functional area in the industry (i.e., manufacturing, quality, R&D, commercial), need to figure out how we can make this important science more accessible to populations around the world. 

  7. 4 “Hot Takes” On Cell & Gene Therapy Manufacturing From Advanced Therapies Week 2023 1/24/2023

    There is truly no article more difficult to write than a takeaway article from a conference. But as I recently spent the past week attending various panels and hearing different perspectives at Phacilitate’s Advanced Therapies Week, I wanted to attempt to do “the impossible” (for me): Share four of the burning manufacturing takeaways that jumped out at me most during the week.

  8. ARW's C&G + RNA Manufacturing Must-Reads (New Year's Resolutions Edition!) 1/12/2023

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.

  9. Cell & Gene Comparability: FDA's Recommendations For Coping With Change 1/5/2023

    I wouldn’t say the FDA’s recent C&G CMC town halls provided us a clearer blueprint from which we can proceed in answering our biggest comparability questions. However, we did receive some helpful high-level reminders and/or clarifications during these town halls, several of which I’ve summarized below. 

  10. Defining The RNA Therapeutics Industry In 2023 1/3/2023

    Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.