Blog | December 1, 2022

ARW's C&G+RNA Manufacturing Must-Reads (Christmas Light Edition!)

Source: Cell & Gene Collaborative
ARW Edit Headshot 2

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 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.

It was recently National Christmas Lights Day. As such, it only made sense to accompany the must-reads below with several best outdoor “lighting” practices to ensure your yard decorations — along with your professional deliverables — are less like Chevy Chase in Christmas Vacation and more like this family from New York with their Guinness World Record-winning 686,811-light display. (Santa) Hats off to the overachievers that had the patience to count those lights.

First, get inspired by previous masters of exterior illumination

  • Look no farther than this “bright light”: I still (and will always) owe former FDA Commissioner Scott Gottlieb a debt of gratitude for allowing me to ambush his COVID tour last year and for patiently answering my questions about the future of CGT CMC for this Dec. 2021 Cell & Gene Collaborative article.

Map out your grand vision: Know which type(s) of light(s) will create the desired visual effect & atmosphere

Invest in more efficient lighting technology

  • When it comes to viral vector manufacturing, AAV is that neighbor whose LED-laden yard brings all the oglers. But the LVV space next door is working just as hard to put on a good, cost-effective show. Feast your eyes on this article by several researchers at National Research Council Canada outlining the pros and cons of current/upcoming LVV process innovations that will improve manufacturing/cost efficiency.

Don’t bite off more than you can chew

  • While I celebrate your efforts to recreate your molecule — and map out its biological cascade — in twinkle lights on the roof of the manufacturing facility, that won’t distract the FDA from your biggest GMP shortcomings.
  • As RAPS reports here, the FDA’s onsite inspections are becoming a more frequent occurrence post-COVID lockdowns. In turn, of the 62 FDA warning letters issued in 2022, 42 were issued following an onsite inspection.

Double (& triple) test that your lights and outlets work

Have someone hold the ladder as you climb it. Or, you know, just call a professional like the rest of us

  • My parents called their ladder “the widow maker” for a good reason.
  • Forecasting the future outsourcing needs of the ATMP industry seems just as perilous as venturing up a rickety ladder. In the second part of a three-part series on the ATMP outsourcing paradigm, I highlight some of the business and manufacturing considerations/challenges CDMOs are facing as they strive to meet innovators’ not-yet-standardized manufacturing needs.
  • A great counterpart to my article above is this one — “ATMP Report Identifies Outsourcing Realities” — in which my colleague strings together various data points from ASGCT’s Q1 2022 report to clarify the current/future outsourcing landscape.

Thank your [insert family member here] for teaching you “everything” you know about exterior illumination