Cell & Gene Collaborative Blog

1. ARW’s CGT+RNA Manufacturing Must-Reads (BAD PICKUP LINES EDITION!) 9/21/2023

   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. From Capacity To Comparability: The Shifting Onus In Cell & Gene Therapy Outsourcing 9/18/2023

   As we continue progressing beyond the COVID (i.e., the seller’s) economy, both Haskett and Graskemper agree we’re steadily seeing biotechs taking on a much more empowered role in negotiating with and securing CDMO partners. But they also see several shifts in the CGT development landscape that could impact both biotechs and their outsourcing partners equally — for the better, or if we’re not careful, for the worse.

3. ARW’s CGT+RNA Manufacturing Must-Reads (GOOGLE SEARCH EDITION!) 9/11/2023

   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.

4. Sarepta’s FDA Adcom: Manufacturing Comparability In The Real World 9/8/2023

   There are a few must-know details about the why & how of Sarepta’s comparability exercise, which I’ll outline for you here. But it wasn’t the facts and figures underpinning the comparability assessment itself that I found the most noteworthy; rather, this adcom served as an important reminder about the overall role comparability can and likely will play in the regulation of our advanced therapies moving forward.

5. ARW’s CGT+RNA Manufacturing Must-Reads (COMPLAINTS EDITION!) 8/29/2023

   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. FDA To Sarepta’s Gene Therapy: “Express Yourself…Maybe?” 8/21/2023

   Though we cling to — and simultaneously despair over — the fact that regulatory experiences are product-specific, the hurdles/debates Sarepta faced remind us of the scientific and clinical complexities our future CGT products will no doubt be faced with during their own BLA reviews.

7. ARW’s CGT+RNA Manufacturing Must-Reads (Weird Contest Edition!) 8/11/2023

   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.

8. “Alice In [The mRNA] Wonderland:” 3 Realities Facing The mRNA Industry 8/7/2023

   The mRNA industry is an exciting place to be, and I have no doubt we will celebrate some significant triumphs in the future. But there are three critical realities (or perhaps difficult truths) I was reminded of during the mRNA Therapeutics Summit worth reiterating to keep us grounded through all our uninhibited dreaming.

9. ARW’s CGT+RNA Manufacturing Must-Reads (OUTLANDISH ‘HOLIDAY’ EDITION!) 7/31/2023

   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.

10. A Meditation On Change In The CGT Manufacturing Space 7/31/2023

    A few weeks ago, I published an article recapping my biggest takeaways from the PDA ATMP conference. Throughout the many technical discussions of the two-day event, I was predominantly struck by how often the conversation circled back to the importance of humility and self-improvement in our CMC. Since publishing that article, I’ve continued to read and hear more about the importance of “growing up” in CMC.