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.
Occasionally, I have readers who will go above and beyond and suggest potential themes for future newsletters. This week, you can “thank” a fellow reader for recommending “bad pick-up lines” as the creative theme. Regardless of your relationship status, please let these “charmers” be a reminder to love the one you’re with and/or yourself. Or, if you’re allergic to affection of any kind (#preach), let these must-read articles be your excuse to keep avoiding all human contact. Here’s to keeping ATMPs sexier than these pick-up lines.
You are hotter than the bottom of my laptop.
- Though we may all secretly hope someone will say this to us, when it comes to our ATMPs, please note: a significantly “hotter” (i.e., a much higher quality post-change product) may not actually be “comparable"... according to page 2 of the FDA’s comparability guidance.
- Can I get a “yay” for… mediocrity?
- For those of us who are dedicated to improving our therapies’ quality and/or scalability via process changes, we were recently privy to an incredible case study on comparability via the Sarepta gene therapy adcom meeting. Here, in part two of this two-part article, I outline the basics behind the change and why Sarepta ultimately had to perform a clinical comparability study.
- For those who want a nice refresher on the FDA’s comparability guidance itself, I’d refer you to this BDO blog post that walks us through some of their high-level takeaways and best practices.
Want to go half on a baby?
- I’m good, thanks — but, given some of the innovative risk-sharing/contracting practices happening in the CGT outsourcing world, I daresay you could find a CDMO who’d dig this question.
- If you’re looking to get a better (i.e., more quantitative) picture of gene therapy CDMOs, Industry Standard Research recently released its 2023 Gene Therapy CDMO Benchmarking study. Though it costs as much to read as having an actual baby, I hate to break it to you — the best things in life just aren’t free.
- Speaking of innovative outsourcing models, kudos to my colleague Louis Garguilo of Outsourced Pharma for providing a look into the rise of the “cleanroom on demand” or “bridge facility” outsourcing model. Though it’s a few months old, it’s a worthwhile refresher on how leading companies like Moderna have employed hybrid outsourcing strategies.
Do you believe in love at first sight, or should I walk by again?
[FACILITY SITE SELECTON]
- For what it’s worth, you should always make someone walk by again, and again — the bigger the crowd watching, the better.
- In fact, some might argue there is no such thing as love at first “site,” for a variety of different reasons. Check out this blog post that provides a number of important CGT facility site-selection tips, including (but not limited to) how to establish your manufacturing baseline needs and site assessment checklist.
Did it hurt when you fell from the vending machine? Because you look like a snack.
- I’ve always dreamt of finding someone who looks at me the way I look at a sprinkle donut.
- Speaking of ogling, there’s a lot of exploration being done to better understand mRNA’s “assets.” For a wide-ranging exploration of the pros and cons of the different methods being used to characterize mRNA today, check out this review article from Mass Spectrometry Reviews.
- But if you want to get even more up-close and personal, check out mRNA’s [poly A] tail:
If you were a booger, I’d pick you.
You dropped something... my jaw.
Well, here I am. What are your other two wishes?
If you were a flower, you’d be a damnnnnn-delion
- I love me some good word play.
- If you enjoy listening to people saying words to you instead of singing them — also known as a podcast — here are a few recommendations, starting with my colleagues’:
- Erin Harris’ Cell & Gene: The Podcast — the latest guest of which was none other than the FDA’s Peter Marks, who walks us through the current regulatory landscape for base and prime editing.
- Matt Pillar’s Business of Biotech Podcast. He most recently featured the CCO Dan Kirby of cell therapy company Orca Bio. If you’re preparing to move into pivotal trials and thinking about commercialization, this one is worth a listen.
- Quality folks, be sure to check out the lineup at the newly launched, “Let’s Talk Quality: The Podcast,” hosted by Hemish Ilangaratne. Episode one on scaling quality functions featuring Sangamo’s Chief Quality Officer and Episode 2 on adapting, overcoming, and improvising as a quality leader with the VP of Mustang Bio caught my eyes in particular.
- The Drug Solutions Podcast hosted by the Association for mRNA Medicines’ founder Chris Spivy recently featured the CIO of Maravai LifeSciences and the CEO of Acuitas Therapeutics discussing the past, present, and future of mRNA.