Blog | August 29, 2023

ARW's CGT+RNA Manufacturing Must-Reads (COMPLAINTS EDITION!)

Source: Cell & Gene Collaborative
Anna Rose Welch Headshot

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

Complaints department-GettyImages-628711862

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.

The last edition of must-reads was sent out on August 24, which is also known as weather complaint day. Though whining about the sun/summer weather is one of my favorite activities, when I first came across this “holiday,” I accidentally overlooked the weather part and was much more excited by the concept of a “National Complaint Day.” So, please, join me in a/my cathartic airing of grievances below, accompanied by your (much more productive) must-reads. Ugh.

Having dreams is exhausting.
[THE STATE OF mRNA]

  • I am (mostly) kidding. But as much as I promise to be a foremost champion of the many dreams in the mRNA space, we also can’t forget the importance of practicality.
  • In keeping with this odd (and oxymoronic) mix of idealistic realism, I wrote a piece outlining my three biggest “reality checks” from the 2024 mRNA Therapeutics Summit — because, as I argue in the article, we can’t and won’t always be Alice in mRNA Wonderland forever.
  • If you’d also like another perspective and a few additional takeaways from the same event, I’d refer you to this pithy blog post, the personal approach/tone of which makes me think the author and I may be kindred spirits.
    • Kyle, if you’re reading this, can we be friends?

Once again... please refer to email 475 of 513; we can’t be ANY clearer.
[REGULATORY]

  • As you curse your way through your inbox to find your much-needed answer from the FDA, you may also want to remind yourself of the types of in-person meetings that are currently at your disposal.
  • Luckily, there are two resources that can help you out with this:
    • Several folks from the consulting firm Allucent are putting together a 5-part blog series outlining the meeting types and best practices for making the most of each type. We start here in part 1 with a primer on the meetings and their timelines and how to go about requesting a meeting.
    • If you’re interested in a cell-therapy-specific regulatory approach, I’d encourage you to register for this upcoming ARM regulatory considerations webinar taking place on September 26 at 11 AM ET.
  • Now before you complain about the lack of staffing at the FDA, I’d like to dampen your (albeit much deserved cynicism) with this article in which Peter Marks outlines the positive progress being made in reorganizing and staffing the OTP.

Why is having dreams so %$^#&*@ EXHAUSTING.
[GENE EDITING REGULATORY]

I can’t see clearly now — the rain’s not gone.
[ANALYTICAL DEVELOPMENT]

Your product promised an otherworldly experience, but I am still stuck on the $%#& Earth.
[TOOLS & TECH]

  • I, too, would like to speak to Gravity’s manager.
  • But some folks are keeping life here on earth interesting, including the folks at DeciBio who published a useful graphic on LinkedIn breaking down the cell therapy tools space (i.e., consumables, instruments, and ecosystem players). This graphic is part of a forthcoming Cell Therapy Manufacturing Market Report 2023-2028. You can sign up via the LinkedIn post above to be notified of its publication.
  • To drill down a bit farther into the cell therapy tools space, this article in Chemical Engineering Science characterizes mixing and fluid dynamics in an automated CAR-T cell therapy bioreactor to further improve mixing performance during cell expansion.

I’ve got 99 problems and potency is one.
[POTENCY ASSAYS]

My ice cream cone is melting #Pissed
[STABILITY/CRYOPRESERVATION]