From The Editor | February 8, 2024

ARW's ATMP Manufacturing Must-Reads (OPERA EDITION!)

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

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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. Once a month, 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.

Not only is it almost Valentine’s Day, but February 8 is Opera Day. And, as it turns out, there are some incredibly romantic opera quotes out there that not only capture the “romance” of this season but which I strongly believe will leave you feeling the love for the important work you do day in and day out. Or not. Probably not — but it’s the thought that counts, right? Please also note, this roundup pairs nicely with chocolate.

I speak of love awake, I speak of love in my dreams, to the water, the shadows, the mountains, to the flowers, the grass, the fountains. ~ The Marriage of Figaro
[PHACILITATE ATW 2024 EVENT RECAP]

Put on the costume and the face in white powder. The people pay and laugh when they please ~ Pagliacci
[SUPPLY CHAIN PANEL DISCUSSION]

  • Well, we won’t be face-painting, and thanks to a sponsorship from Thermo Fisher, you won’t have to pay to laugh with us. But my forthcoming Advancing RNA panel discussion on the mRNA (in-bound) supply chain with Sanofi’s Greg Troiano and Life Edit’s April Sena will be a fantastic and educational spectacle, nonetheless.
  • Register here to join us on Feb. 21 at 11 AM ET to discuss the health of the current mRNA-LNP supply chain and how these experts are selecting vendors, navigating GMP principles, and working to reduce cost of goods for mRNA vaccines and therapeutics.

Son io. Eh si. Il problema si son io ~ Anti-Hero
[EDUCATION]

  • Yeah, you didn’t realize translating Taylor Swift lyrics into Italian would be so damn operatic, did you?
    • You’re welcome.
  • Ok, T. Swizzle may not exactly be “opera,” but her song “Anti-Hero” rewritten to become “Antigen Hero” by the geniuses at the National Center for Therapeutics Manufacturing is beyond worthy of ticket sales for the way it entertains and educates.
  • Making mRNA more relatable to the general public — as the video above does (to an extent) — will be essential to the sector’s long-term commercial growth, especially because, as I argue in one of my latest columns, mRNA’s ability to be used as a vaccine and a therapeutic poses some intriguing regulatory and public relations challenges.

Have you come down from heaven, or am I in heaven with you ~ Il Trovatore
[REGULATORY]

  • I don’t know where the ^%$& you think you are, but this is an FDA Townhall. So…
  • Speaking of which, the FDA does have a few events coming up, starting with:

Farewell past, happy dreams of days gone by. The roses in my cheeks already are faded ~ La Traviata
[FUTURE CGT TECHNOLOGIES]

  • Well, before you go slamming the casket lid closed, these new therapeutic “scorchers” should make you feel like you have at least one foot outside of the grave.
  • ARM and Catalyst Health recently released a new report, "Preparing for the Future: Emerging Technologies Shaping the CGT Landscape." This report highlights a really nice “cast” of ATMP characters, all of which are expected to add some drama to the regulatory paradigm and chase Wagner’s Valkyries away. (Think: In Vivo CAR-Ts, non-viral delivery, and RNA therapeutics, to name just a few!)

None shall sleep! None shall sleep! ~ Turandot
[CELL THERAPY ADVANCES]

Pure Goddess, whose silver covers these ancient sacred plants, we turn to your lovely face unclouded and without veil. ~ Norma
[ANALYTICS]

Ah, come back again as you were then, then when I gave you my heart, ah come back to me! ~ Norma
[COMPARABILITY]

Love is a rebellious bird that nobody can tame, and you call him quite in vain if it suits him not to come ~ Carmen
[LNP DELIVERY]

Hell’s vengeance boils in my heart; death and despair blaze about me. ~ The Magic Flute
[CRYO CONSIDERATIONS]

  • Ok, first of all, chill.
  • To help you out with that, a few really cool folks at BMS penned this Outsourced Pharma article presenting common FAQs about cryo-shipping for CAR-T therapies. They also break down the main cast of characters (i.e., cryo-shippers & logistics providers) and how best we can qualify and validate potential partners.
  • For those of you who really just can’t stop your heart from boiling, I see you (I really do) and offer a slightly less frigid article by a team of Roche experts investigating mRNA-LNP shelf-life stability under nonfrozen conditions. [Institutional access required.]