ARW's C&G Manufacturing Must-Reads ("Tabloid" Edition!)
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
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.”)
So, here’s a “permanent” copy of my C&G Manufacturing Must-Reads newsletter that was delivered on January 13, for all you practical people who, like Carlin, abhor the question, “Where is it?”
Man[ufacturer] On The Moon!?
“I saw pharma plant beamed up into the sky!”—Anonymous woman tells all!
- How has the CGT industry’s struggle with manufacturing capacity evolved in the past year? What does “manufacturing maturity” mean for firms in 2022? Where is the most growth necessary? Will a CGT company land on the moon — and which one?! Four executives from Kiniciti, Renovacor, Celularity, & The Cell & Gene Therapy Catapult share their hot takes in my 2022 outlook feature.
Doomsday prophet takes Prozac, predicts eternal life for all!!
The Shocking REAL stories behind the scenes of pharma’s medical breakthroughs!
- Prior to the holidays, I hosted a small Cell & Gene Collaborative forum featuring Dark Horse Consulting’s COO and Managing Partner, Katy Spink. What emerged from that conversation was a series of five New Year’s Resolutions for CGT manufacturing teams. Feast your eyes on Spink’s advice for firms in resolutions 1-3. (4 & 5 forthcoming!)
“Bad Blood:” Taylor Swift song cured my blood cancer!
Inside: You won’t believe what she’s singing about in her new album
Plus! Oprah — "YOU get a cell therapy, And YOU get a cell therapy!”
- As it’s one of my greatest wishes for you to finally acknowledge your begrudging love of Taylor Swift, I decided to speed things along by putting together “The ‘Swifty’s’ Guide To The Top 5 Cell & Gene Manufacturing Evolutions In 2021.” In a series of five short(ish) blog posts — with song recommendations! — I unpack the themes that emerged last year in the CGT manufacturing space, along with lessons learned & predictions for their evolutions in the year ahead. All five articles are catalogued in the link above, but here are the individual titles in descending order:
- #5: Talent Crunch Compels Cell & Gene Industry, Applicants To Get Creative
- #4: Next-Gen Delivery Dreamers Are Alive & Well, But Patience Is A Virtue
- #3: In A CGT Galaxy Close, Close To Us All, The “Cell Wars” Are (Not Really) Brewing
- #2: In Build Or Buy World, Knowledge Management Is The Real Consideration
- #1: Cell & Gene Therapy Manufacturing Leadership: An Evolving Definition
Long-lost regulatory guidance found!
FDA thrilled: answers all their questions AND contains meaning of life!
- For the cell therapy and next-gen delivery nerds among us, you’ll likely find this news out of the European Medicines Agency noteworthy. The Agency has launched the Regulatory Science Research Needs Initiative, which features upwards of 100 topics that deserve additional research and funding. On pages 5-7 (or starting 6/39 via the PDF page counts) the agency outlines its interest in decentralized manufacturing of ATMPs and novel manufacturing and delivery approaches (e.g., digital manufacturing, AI learning, nanotechnology, and Pharma 4.0, etc.)
- The CGT field is making the FDA’s Peter Marks happy; after years of emphasizing CMC, he tells Cell & Gene Therapy Insights in this Q&A that 2021 was the year the industry started talking about the right things — for example, CQAs, potency, and QBD. Hear him dish out his thoughts on autologous cell therapy manufacturing standardization, regulatory alignment, gene editing, and much more!
- “Nobody Expects The Omicron Inquisition!” What Monty Python was really trying to tell us in his famous skit is that the FDA has postponed all non-mission-critical domestic manufacturing facility inspections at least through January 19. (Thanks, Omicron.) The revival of non-mission-critical foreign inspections, which were scheduled to begin in February 2022, have also been postponed.
“CDMO turned our drug into a radioactive lizard”
“We ordered a gene therapy, not a genetic monstrosity!"
- In his 2022 outlook article published in Life Science Leader magazine, my Outsourced Pharma colleague Louis Garguilo tackles the emerging needs and ongoing debates in the outsourcing world. Though the article’s SMEs aren’t with CGT companies, the topics they address are still relevant. Topics covered include: the need for and benefits of “U-DMOs” (i.e., university spin-off or university-affiliated CDMOs); considerations for building your own capacity; and winning the attention of the big CDMOs when reaching late-stage clinical development.
- In 2021, we observed the outsourcing sector’s mad dash to build up the required CGT expertise and capacity. As this BioProcess International CDMO roundup demonstrates, 2022 is off to a similarly impressive start, this time with several outsourcing firms garnering some much needed investor attention.
Women leaned in farther, took over entire earth!!!!
Bye, bye, “bombshell,” hello “girlboss”
- I love Endpoints’ annual Women In Biopharma series. Their 2021 Top 20 class — which features several leaders within the AAV and CAR-T space — is chock-full of great leadership advice.
SLACK JAWED: man breaks jaw on fossilized shark vertebrae
“it looked like an oatmeal cookie!” — man
Also inside! (Sizzling Triple Issue!)
3 Cats Steal Vitamix!
These Flying Squirrels CAN Read Your Mind!
Biggest ice cream melt-down in history!!