CELL & GENE COLLABORATIVE BLOG

ARW's CGT+RNA Manufacturing Must-Reads (Oscar The Grouch 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..

Where Fly-Fishing Meets mRNA: The Art Of mRNA Immunogenicity
In the final installment of this two-part series comparing fly-fishing and mRNA immunogenicity, I summarize some of the basic immunology-centric underpinnings of our mRNA development efforts and the enduring immunogenicity questions and concerns shaping and re-shaping these efforts today.
Continue Reading..

ARW’s CGT+RNA Manufacturing Must-Reads (Greeting Card 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 Fly-fishing Can Teach Us About mRNA Immunogenicity
In part one of this two-part article, I spell out some of the decisions fly-fishermen must make to “trick” a fish, and how these decisions are akin to those of the mRNA industry as we strive to successfully navigate “the enigmatic beast” that is the human immune system.
Continue Reading..

ARW’s CGT+RNA Manufacturing Must-Reads (Pizza Cake 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 (Epitaph 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..

Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned
One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply...
Continue Reading..

Moderna’s Global mRNA Manufacturing Strategy: A Closer Look
In part 2 of this 3-part series, I argue Moderna’s strategy for scaling its mRNA vaccine manufacturing paradigm globally is one of the best examples the ATMP space has today of what it means to begin with and keep the end in mind.
Continue Reading..

Beyond Moderna’s Regulatory Legacy: (Re)defining The mRNA Regulatory “Norm”
It’s unlikely we will need to burn nearly as much “midnight oil” as Moderna and the regulatory bodies did during the pandemic. However, I share Moderna's unique experiences because they’re a great reminder that the mRNA therapeutics industry is set to face a much different regulatory challenge moving forward.
Continue Reading..

Moderna’s Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance
We may no longer be living in the fast-and-furious days of Emergency Use Authorization, nor are we all working strictly on mRNA vaccines. But after listening to Moderna’s Director of Regulatory CMC Chris Kelly share his whirlwind regulatory experiences, there were still several broad takeaways for companies navigating this nascent space.
Continue Reading..
ARCHIVED ARTICLES
- ARW’s C&G+RNA Manufacturing Must-Reads (International Women’s Day Edition!)
- Cell & Gene Therapy COGS: Words Of Wisdom To ‘Keep The End In Mind’
- Cell & Gene Therapy COGS: Progress & Pitfalls In Our Quest For Affordability
- ARW’s C&G+RNA Manufacturing Must-Reads (Pinocchio Edition!)
- ARW’s C&G+RNA Manufacturing Must-Reads (I LOVE YOU, PIZZA Edition!)
- Cell & Gene Manufacturing Risk Vs. Benefit: How It’s Reflected In Our FDA Interactions
- GMP Principles: The True Star Of Cell & Gene FDA Interactions
- ARW’s C&G+RNA Manufacturing Must-Reads (“Compliment” Your Spouse Edition!)
- Metaphorical mRNA: An Argument For (More) Creativity In RNA Therapeutics
- 4 “Hot Takes” On Cell & Gene Therapy Manufacturing From Advanced Therapies Week 2023
This website uses cookies to ensure you get the best experience on our website. Learn more