Cell & Gene Collaborative Blog
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What Violin Making Can Teach Us About mRNA Therapeutic Quality
8/8/2022
Managing the mRNA supply chain and working in mRNA process development may not look anything like the work a luthier does to hew an instrument from an ancient spruce tree. But violin craftmanship actually serves as a fantastic metaphor for the challenging work the mRNA therapeutics space is tackling in sourcing and qualifying raw materials and optimizing the critical IVT reaction.
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ARW's C&G+RNA Manufacturing Must-Reads (Amusement Park Edition!)
8/1/2022
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 Cell & Gene + RNA Manufacturing Must-Reads (Mac & Cheese Edition!)
7/15/2022
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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What Playing RISK Can Teach Us About mRNA Manufacturing
7/11/2022
On the surface, it may seem as though there is little in common between playing a board game and manufacturing mRNA therapeutics. But as I see it, strategizing, playing, and winning at RISK is highly analogous to the challenges mRNA therapeutics companies will face as they strive to achieve a well-controlled and understood commercial scale manufacturing process.
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Bluebird Bio FDA AdCom: 3 Key Takeaways For The Cell & Gene Therapy Industry
7/6/2022
Below, I’ve boiled down the 15 dizzyingly technical hours comprising bluebird bio's two FDA AdCom meetings into three high-level takeaways that speak to the opportunities and limitations facing CGTs and their all-important CMC frameworks.
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ARW's Cell & Gene Manufacturing Must-Reads (Asteroid Day Edition!)
7/1/2022
Day-in and day-out, I write, read, listen to, and watch as much content as I can about C&G therapy manufacturing, in particular, and/or other C&G 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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Bluebird Bio FDA AdCom: For Cell & Gene Manufacturing, FDA Approval Is Just One Of Many Milestones
7/1/2022
This is the final installment of a three-part series discussing the main takeaways from bluebird bio’s recent FDA AdCom evaluating its two ex-vivo gene therapies: eli-cel in cerebral adrenoleukodystrophy (CALD) and beti-cel in β-thalassemia.
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Bluebird Bio FDA AdCom: Your Viral Vector's Future Is In The Eye Of The Beholder
6/29/2022
This is the second in a three-part series discussing several main takeaways from bluebird bio’s recent FDA AdCom evaluating its two ex-vivo gene therapies: eli-cel in cerebral adrenoleukodystrophy (CALD) and beti-cel in β-thalassemia.
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Bluebird Bio AdCom: Risk Vs. Benefit A “Living” Measurement For Commercialized CGTs
6/27/2022
This is the first in a three-part series discussing several main takeaways from bluebird bio’s recent FDA AdCom evaluating its two ex-vivo gene therapies: eli-cel in cerebral adrenoleukodystrophy (CALD) and beti-cel in β-thalassemia.
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From Manufacturing To C-Suite: “Scaling Up” C&G Therapy Communication
6/20/2022
Though "communicate often" is a commonly offered best practice in the CGT space, what is rarely discussed is what this can and should look like, especially when it comes to elevating information from the manufacturing floor/team up to the C-suite. Mark Gergen, CEO of Poseida Therapeutics, gives us a great idea of what this can look like for growing CGT companies.