Cell & Gene Collaborative Blog
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Overcoming CGT Potency Assay Woes: 4 Best Practices
12/21/2022
Here, I share a few of the actionable takeaways I walked away with from the ARM/ASGCT potency assay working session in the hopes they will be a complementary exploration of the analytical challenge impacting every ATMP company.
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ARW's Cell & Gene + RNA Manufacturing Must-Reads (The 12 Days Of Christmas Edition!)
12/15/2022
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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CGT Potency Assays: When Will We Wake Up From The Nightmare?
12/12/2022
Here, I offer my biggest takeaways from a recent ARM/ASGCT workshop on one of the most popular topics to gossip about both in and outside the analytical labs: Potency assays. In part one of this two-part article, I start by unpacking what I see as the most prominent knowledge gaps and questions underpinning the industry’s potency assay challenge.
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mRNA & RNA Therapeutics In 2023: Where Do We Go From Here?
12/7/2022
To figure out what the future holds for companies in the RNA sector of the ATMP space, I sat down with four executives to discuss their wildest hopes, dreams, and expectations. As you’ll note, there is no shortage of work facing the RNA therapeutics industry in the year(s) ahead. But there’s also a lot for which we can hope.
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ARW's C&G+RNA Manufacturing Must-Reads (Christmas Light Edition!)
12/1/2022
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 C&G+RNA Manufacturing Must-Reads (The Little Mermaid Edition!)
11/18/2022
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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"Lean On Me": Defining Risk-Sharing In Cell & Gene Therapy Manufacturing Partnerships
11/1/2022
While I cannot define precisely what (or which) shape(s) risk-sharing will take for the multitude of unique CGT products in the works, I’ve been privy to several conversations that go a long way toward defining the current state of these evolving ATMP outsourcing partnerships and business models.
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“Risky Business:” How Cell & Gene Therapies Are Upending Partnership Models
10/25/2022
This article is the final installment of a three-part series examining how advanced therapy scientific and quality expectations are impacting outsourcing business practices/models today and, hopefully, creating a foundation for greater risk-sharing in the future.
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ARW's Cell & Gene + RNA Manufacturing Must-Reads (Chef's Edition!)
10/21/2022
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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Beyond “The Building Phase”: Evolving The Cell & Gene Outsourcing Paradigm
10/18/2022
This article is part two of a three-part series examining how advanced therapy scientific and quality expectations are impacting outsourcing business practices/models today and, hopefully, creating a foundation for greater risk-sharing in the future.