By Anna Rose Welch, Director, Cell & Gene Collaborative
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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.
When this newsletter was sent out on Sept. 8th, it was National Actors Day. So, naturally, I decided to craft each section of this newsletter in the voice of a particularly demanding and eccentric acting coach/director. This director has some specific instructions, acting exercises, & reading materials for an aspiring actor — in this case, you — to bring their cinematic vision (a.k.a. an ATMP-filled universe) to life on the big screen. Break a leg!
“Picture Yourself In A Manufacturing Facility In A Universe Far, Far Away”
Look, I really didn’t want to suspend you from the ceiling. But you just weren’t embodying the energy that you should be. You are an astronaut with bioprocessing skills: you’re UNTOUCHABLE! This new universe is your playground! Where is your sense of awe?
There you go — look at that smile! We’re in outer space now!“
Scientific Tongue-Twisters Are No Excuse For Mumbling Your Lines”
In fact, I’ve found nothing quite improves your diction like reciting gene editing vocabulary five times fast.
Now, say it all again, but this time, pretend you’re British.
Remarkable. You sound so much smarter.
“Understand The Conflicts That Drive Your Character (Insane): Waste, Contamination, & Patents — Oh, My!”
Now that we’ve fixed your chronic mumbling, stand up and show us just how much your character cares about single-use technology and sustainability.
...I think some homework is in order.
- Grab a white-board, a marker, and all the current research around the environmental impact of fixed-facility batch manufacturing processes and flexible facilities with continuous manufacturing [CM] processing. You’re going to want to take down some figures:
- Secondly, for next class, come dressed to recite all your lines while in a split. If you’re going to embody a character who truly understands “flexible facilities,” you should be flexible, too.
Talk about contamination! You know what, add these articles to your homework, too:
Nope — eyes over here; those donuts are only for the crew.
- How did the crew win “exclusivity” over the donut table, you may be wondering?
- Well, as anyone in biotech knows, exclusivity/IP are the rainbow sprinkles on the donut for any company. But the increasingly dense patent landscape is turning the mRNA LNP space into a highly entertaining soap opera. [The Current mRNA/LNP Patent Litigation Landscape]
“The Mood We’re Going For Is: ‘Stuff Is Hard, But It’s Cool, Too,’ Not: ‘I Hate You, Science’”
Now, when you throw down the batch records and say, “Will I ever understand what this #$%^&*@! means?!” I need you to precisely convey both apprehension and excitement over the challenging but limitless opportunities facing you. Think about your first day of high school!
Or, if that’s too traumatizing, put yourself in the shoes of these grown up and well-adjusted, NIIMBL-funded project planners & participants. [NIIMBL Announced $15.8M To Fund 14 New Biopharmaceutical Manufacturing Projects].
Two ATMP-centric projects worth noting received funding, including:
- University California-Davis and partners Eli Lilly, Pall Corp/Cytiva, & Solano College are launching this incredibly important program: “Public-Private Partnership Strategy for Workforce Training in CGT Manufacturing.”
- Together, University of Delaware, MilliporeSigma/EMD Serono, and Agilent are tackling: “Innovative Scalable Technologies for Production of Cell Therapies.”
“Dig Deep — But Regulate Your Emotions; Less Is Always More...”
Right now, your face should be saying, “I’m an inquisitive engineer,” not “I like you, but I want to kill you.” Turn that “Joker” smile down notch.
- Finding a good balance emotionally — and scientifically — can leave anyone feeling unhinged. That’s why I’d like to remind you that the FDA is going to be hosting a virtual Gene Therapy CMC Town Hall Meeting on Sept. 29, at 11:30 AM ET to provide some sweeping guidance and address your biggest questions, concerns, confusions, grievances, etc., etc.
- All the best actors study the performances of their idols — why should drug developers be any different? Dark Horse Consulting penned this in-depth piece asking important questions about what bluebird bio’s Zynteglo approval and the FDA’s AdCom format for Zynteglo/eli-cel could mean for future regulatory thinking/decision-making.
- If you wish to re-experience the bluebird bio AdCom, I humbly offer 3 of my own takeaways, one of which includes some Shakespeare who knew a thing or two about how to present one’s self on the stage.