Blog | August 11, 2023

ARW's CGT+RNA Manufacturing Must-Reads (Weird Contest Edition!)

Source: Cell & Gene Collaborative
Anna Rose Welch Headshot

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

GettyImages-483600588

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.

This week, August 6-12, is Weird Contest Week. So, I’ve sorted your must-reads according to a made-up slogan for some of my absolute favorite contests in existence, along with a link to each so you can start planning your trips immediately. Though I came up with the “slogans” for these contests, I had nothing to do with the brilliance of the contests themselves. Stay weird.

“#Resurrected!” @ Hunky Jesus & Foxy Mary Contest
[COMPLIANCE]

“World’s #1 Pallbearer” @ Frozen Dead Guy Days
     *no death certificate required for entry
[mRNA/LNP CRYOPRESERVATION]

  • You carried the winning coffin in a casket race, you say? ...
  • Speaking of unstable... this is an older article (January 2023), but still presents a well-rounded look at strategies for mitigating mRNA’s instability. Outside of the inherent instability of the molecule itself, I particularly appreciated this article’s attention to the unique handling challenges of working with mRNA in your/your partners’ facilities.
  • Likewise, we’re still trying to understand how storage conditions (temperature) and cryoprotectants (particularly sugars) impact the stability and efficacy of our LNPs. This study in Advanced Healthcare Materials unearths some answers for us on how multiple freeze-thaw cycles and temperature fluctuation can impact the stability, encapsulation, and transfection efficiency of LNPs and receptor-targeted nanocomplexes.

“It’s a bird! It’s a plane! It’s a... Bathtub Regatta?”
[COMPARABILITY]

“Truckles will roll” @ Cooper’s Hill Cheese-Rolling & Wake
[REGULATORY]

  • Most of us love cheese — but would you really go running & rolling down a mountainside to catch a wheel of cheese that’s going 65 mph?
    • Put your (delightfully unbroken) hand down.
  • Nothing in pharma moves quite as fast as a cheese wheel downhill or into your mouth on a Tuesday night. But that doesn’t mean it shouldn’t. Here, Raz Eliav of Beyond CMC outlines “The Digital Future of CMC Regulatory Affairs,” showcasing recent technological initiatives the FDA has implemented to get the current document-heavy industry-agency communication schemes rolling more swiftly toward a digital future.

“My milkshake brings all the worms out of the yard” — @ World Worm Charming Championships
     *Hoeing encouraged
[OUTSOURCING]

“My phalanges are more swole than your biceps” — @ World Toe Wrestling Championship
[LNP MANUFACTURING]