Cell & Gene Collaborative Blog

1. ARW's CGT+RNA Manufacturing Must-Reads ('TWAS THE NIGHT BEFORE CHRISTMAS' EDITION!) 12/14/2023

   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 CGT+RNA Manufacturing Must-Reads (CHOCOLATE MOUSSE EDITION!) 12/1/2023

   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. ARW's CGT + RNA Manufacturing Must-Reads (TEACHER'S ADVICE EDITION) 11/20/2023

   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. Peter Marks: An Early Preview of mRNA, Gene Therapy Platforms 11/13/2023

   Though Marks emphasized that this concept/designation at the regulatory level is still somewhat of a “we’ll-know-it-when-we-see-it” phenomenon, his remarks this summer — as well as a few additional discussions that have occurred throughout 2023 — add a bit more clarity to our understanding of what a gene therapy platform can be.

5. “With This MSA, I Thee Contract:” The “Make-or-Breaks” In CGT Outsourcing Negotiations 11/6/2023

   To help us all feel a bit stronger in the face of a negotiation, Haskett and Graskemper did not shy away from providing their go-to contracting best practices and tips for tackling an MSA and Quality Technical Agreement (QTA). While our discussion was far from exhaustive, they singled out several potentially showstopping areas that demand greater prescriptiveness in our MSAs for the sake of much stronger and long-term outsourcing partnerships. 

6. ARW's CGT + RNA Manufacturing Must-Reads (FORTUNE COOKIE EDITION!) 11/3/2023

   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.

7. What's Mine Is (Maybe) Yours: Risk-Sharing In CGT Outsourcing 10/25/2023

   Here, Haskett and Graskemper walk me through the different nuances of risk-sharing in the current CGT outsourcing space and how they identify the best partner, platform, and intellectual property (IP) strategy when reviewing and (re)negotiating an MSA.

8. ARW's CGT+RNA Manufacturing Must-Reads (ARW IS ON A DEADLINE Edition!) 10/23/2023

   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. ARW's CGT + RNA Manufacturing Must-Reads (STORYTELLING EDITION!) 10/9/2023

   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.

10. “Once Upon A Platform”: A Realistic Look At “Plug & Play” CGT Development 10/2/2023

    We can’t just talk broadly about our need for more advanced capabilities from our outsourcing partners without closely examining the current maturity of CDMOs' AAV-based gene therapy and LVV-based cell therapy platforms. Lucky for us, Haskett and Graskemper shared their top tips and tricks for evaluating the seaworthiness of current CGT platform offerings.