CELL & GENE COLLABORATIVE BLOG
ARW’s CGT+RNA Manufacturing Must-Reads ('TWAS THE NIGHT BEFORE CHRISTMAS’ EDITION!)
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.
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ARW's CGT+RNA Manufacturing Must-Reads (CHOCOLATE MOUSSE EDITION!)
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.
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ARW's CGT + RNA Manufacturing Must-Reads (TEACHER'S ADVICE EDITION)
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.
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Peter Marks: An Early Preview of mRNA, Gene Therapy Platforms
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.
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“With This MSA, I Thee Contract:” The “Make-or-Breaks” In CGT Outsourcing Negotiations
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.&nb...
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ARW's CGT + RNA Manufacturing Must-Reads (FORTUNE COOKIE EDITION!)
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.
Continue Reading..
What's Mine Is (Maybe) Yours: Risk-Sharing In CGT Outsourcing
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.
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ARW's CGT+RNA Manufacturing Must-Reads (ARW IS ON A DEADLINE Edition!)
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.
Continue Reading..
ARW's CGT + RNA Manufacturing Must-Reads (STORYTELLING EDITION!)
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.
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“Once Upon A Platform”: A Realistic Look At “Plug & Play” CGT Development
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.
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ARCHIVED ARTICLES
- ARW's CGT+RNA Manufacturing Must-Reads (BAD PICKUP LINES EDITION!)
- From Capacity To Comparability: The Shifting Onus In Cell & Gene Therapy Outsourcing
- ARW's CGT+RNA Manufacturing Must-Reads (GOOGLE SEARCH EDITION!)
- Sarepta's FDA Adcom: Manufacturing Comparability In The Real World
- ARW's CGT+RNA Manufacturing Must-Reads (COMPLAINTS EDITION!)
- FDA To Sarepta's Gene Therapy: “Express Yourself…Maybe?”
- ARW's CGT+RNA Manufacturing Must-Reads (Weird Contest Edition!)
- “Alice In [mRNA] Wonderland:” 3 Realities Facing The mRNA Industry
- ARW’s CGT+RNA Manufacturing Must-Reads (OUTLANDISH 'HOLIDAY’ EDITION!)
- A Meditation On Change In The CGT Manufacturing Space
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