Blog | February 9, 2023

ARW's C&G+RNA Manufacturing Must-Reads (I LOVE YOU, PIZZA 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.

February 9th was not just an important day because I had lots of great ATMP-centric resources to share, but it also happened to be National Pizza Day. As we approach Valentine’s Day and my adoration for pizza truly knows no bounds, each section of this manufacturing must-reads features a “Valentine” to our beloved, Pizza, and (sort of) to the therapies we work with every day. Enjoy the cheese.

Let me take you back to my place.

You’re so much hotter than your twin, DiGiorno.

  • Frozen pizza is not an acceptable suitor — especially considering < 30 % of the cheese on a frozen pizza is real. Don’t cheat on takeout pizza with frozen pizza. Just don’t.
  • Yes, we always want to be cost-conscious. But we also want the FDA and our patients to see our therapies — and all the materials and processes underpinning them — as a product of the highest quality.
  • Hence why I went through the FDA’s Cell & Gene Therapy CMC townhall transcripts with a fine-toothed comb and isolated several best practices from their recommendations in my latest article, “GMP Principles: The True Star of Our Cell & Gene FDA Interactions.”
  • In the previous article, I touched briefly on plasmid quality, primarily as it relates to viral vector gene therapies. But the popularity of BioPhorum’s recent article “Release Specifications for Plasmid Master Cell Banks, Plasmid DNA” across Life Science Connect’s publications demonstrates the industry’s immense appetite for greater clarity around this critical starting material.

You’re hot then you’re cold but I’ll never say no.

  • There are a lot of ways to consume a pizza (i.e., hot or cold, with a fork and knife or the real way — with your hands.)
  • Not surprisingly, approaches for approving mRNA stability are just as multifaceted. I liked this cleverly titled review: “The Storage & In-Use Stability of mRNA Vaccines & Therapeutics: Not A Cold Case.” Unlike most reviews that focus primarily on drug substance/drug product optimization for improved protein expression, the authors instead walk us through current or emerging strategies for improving stability on the drug substance and drug product (mRNA-LNP) levels.
    • However, this article is truly a smorgasbord of information, with sections dedicated to such critical topics as “stage-appropriate” analytical characterization, product packaging, and regulatory guidance/emerging acceptance criteria — and so much more!

I knead you.

I’d never hide your beauty in a box.

I “chews” you.

  • Asking whether pineapple belongs on a pizza is one topic that will quickly help you determine who your real friends are. (It belongs, btw.)
  • Unfortunately the do’s-and-don’ts of pizza toppings were not one of the topics discussed in this (still fabulous) podcast, Best Practices When Building High Performing CMC Teams.
    • Should an hour be too much commitment, I’d point you to my favorite portions of the discussion:
      • 17:30-36:40 — How to communicate what matters to Tech Ops with your C-Suite and your board, and what that looks like/entails
      • 43:30-49:03 — Good habits to embrace & bad ones to avoid as a Tech Ops leader

In the limpid pools of your pepperonis, I see a new shimmering world.