CELL & GENE COLLABORATIVE BLOG

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Cell & Gene Manufacturing Risk Vs. Benefit: How It’s Reflected In Our FDA Interactions
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.”  Continue Reading..
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GMP Principles: The True Star Of Cell & Gene FDA Interactions
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.  Continue Reading..
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ARW’s C&G+RNA Manufacturing Must-Reads (“Compliment” Your Spouse 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..
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Metaphorical mRNA: An Argument For (More) Creativity In RNA Therapeutics
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.   Continue Reading..
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4 “Hot Takes” On Cell & Gene Therapy Manufacturing From Advanced Therapies Week 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.  Continue Reading..
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ARW’s C&G + RNA Manufacturing Must-Reads (New Year’s Resolutions 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..
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Cell & Gene Comparability: FDA’s Recommendations For Coping With Change
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.   Continue Reading..
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Defining The RNA Therapeutics Industry In 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.  Continue Reading..
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Overcoming CGT Potency Assay Woes: 4 Best Practices
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.  Continue Reading..
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ARW’s Cell & Gene + RNA Manufacturing Must-Reads (The 12 Days Of 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.  Continue Reading..
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Anna Rose Welch





Anna Rose Welch is the director of Cell & Gene Collaborative. In this role, she is forging close relationships with the leading voices and organizations in the cell and gene therapy manufacturing sphere. This includes establishing a peer group comprising Cell & Gene company manufacturing SMEs, conducting interviews and hosting interactive roundtables on the evolving manufacturing paradigm, and authoring thought leadership articles and blog posts via the Cell & Gene Collaborative blog.

Prior to launching Cell & Gene Collaborative, Anna Rose spent five years building an extensive network and editorial following as the Chief Editor of Biosimilar Development. In addition to penning thought leadership on biosimilar regulatory affairs, government policy, and commercialization advances, she was also an active participant in the biosimilar conferences circuit. She was appointed chair or served as a speaker and panel moderator at international conferences, including the World Biosimilar Congress USA, The Biotech Pharma Summit (EU), the CBI Biosimilars Summit, DIA Biosimilars Conference, and the Biosimilar Medicines Group Conference (EU). In 2018, she was invited to Brazil where she addressed members of the Brazilian Ministry of Health, ANVISA, and local biologics and biosimilar manufacturers on establishing national biologics and biosimilar policies. She also represented the publication on a media tour of Bangkok, Thailand in 2017, during which she reported on the country’s efforts to bolster its life sciences industry. In addition to writing for Biosimilar Development, she penned the introductory chapter to the book, Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development (Springer, 2018).

In 2018, her first book of poetry, We, The Almighty Fires, was published by Alice James Books.