Cell & Gene Collaborative Blog
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“Ancillary Materials”
12/2/2021
Hello, procrastination, old friend. You’re a gem
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The Ties That Bind: Engineering A CGT Manufacturing-Centric Culture
11/29/2021
When I met Tenaya Therapeutics CEO, Faraz Ali, we were just starting to emerge from the worst part of the spring 2021 pandemic, by which point navigating the workday from family-filled houses was finally second nature to many of us. This was clearly the case for Ali who carried out our early morning interview in the front seat of his car so as not to wake up his daughters. (Clearly, they have him wrapped around their pinky fingers — as is only right.
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Shall We
DanceTransduce? A CGT CEO's Quest For More Efficient Transduction 11/23/2021In the first of this two-part article, I shared how Dr. Bobby Gaspar, CEO of Orchard Therapeutics, is guiding the company through the challenging — but promising — process of a developing a stable producer cell line for more efficient lentiviral vector production. However, as our conversation continued, we seamlessly moved from one complicated T-word — triple transfection — to another: Transduction.
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Orchard Therapeutics' Hot Pursuit Of A Stable Cell Line For Lentiviral Vector Production
11/18/2021
When Dr. Bobby Gaspar founded Orchard Therapeutics and came on, first as its CSO prior to becoming CEO, he set four goals for the company to successfully manufacture a gene therapy. The first was to select the appropriate stem cell population. The second was to investigate the use of and potentially develop novel transduction enhancers to make the currently finicky transduction process more efficient. The final two — which remain works in progress for a large number of cell and gene therapy (CGT) players today — were to implement automation and to develop a stable producer cell line for lentiviral vector production.
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Who Invited The CAPAs?! Bracing For CGT Manufacturing “Party Fouls”
11/18/2021
When I was in college, the “Kappa’s” were known as the “fun” sorority. This also explains why they were ultimately banned from campus for doing things the school thought were a bit too fun. (And before you ask, no, I have no first-hand knowledge on how or why that happened; I was a hop-skip-and-three-grand-canyons away from the sorority realm.)
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ARW's C&G Manufacturing Must-Reads
11/15/2021
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. But inboxes can be shifty places. (Cue George Carlin on “Losing Things.”)
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Pfizer's Gene Therapy CMC Woes: A (Not So) Cinderella Story
11/11/2021
As a poet and violinist and the daughter of an artist, it makes perfect sense that I’d end up in the technical CGT manufacturing space — said no one in the history of ever. I blame my background and genetics for my endless desire to take creative liberties with the scientific knowledge I glean day in and day out. And, dear reader, for better or worse, my brain has been getting kicked into creative overdrive more and more regularly these days. (You’re welcome?)
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“Ancillary Materials”
11/11/2021
And the Pulitzers for the most entertaining things to read go to…
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Kite Exec Reveals Key Ingredient To “Secret CGT Manufacturing Sauce”
11/5/2021
The dust is slowly settling following the Alliance for Regenerative Medicines’ (ARM’s) Meeting on the Mesa. As I was a virtual attendee this year (fingers crossed for live attendance in 2022!), I’m only just starting to watch the many panels and workshops that caught my eye — starting, of course, with the three manufacturing-centric panels. So far, my favorite, hands-down, was the workshop entitled, “Industrialization of Cell Therapy Manufacturing,” which I’ll no doubt continue to discuss more in depth in the upcoming weeks.
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ARW's C&G Manufacturing Must-Reads
10/29/2021
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. But inboxes can be shifty places. (Cue George Carlin on “Losing Things.”)