By Anna Rose Welch, Director, Cell & Gene Collaborative
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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. 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.
Though I suppose every week feels like “National Email Week,” we were smack-dab in the middle of the official National Email Week when this newsletter was sent around. So, to celebrate that fact, I organized your manufacturing must-reads according to several (no doubt) familiar email “subject lines.” Who knew spam emails could be so closely related to ATMP manufacturing challenges?
ATTN: Unusual account activity detected!!!
3 hawt stepps 2 attract ur souwlmate
RE: Why don’t u like me?
2 boxes GR8 stuff for $5
- I suppose that’s one way we can describe our latest raw materials shipment…
- How we/the regulatory agencies and pharmacopeias define raw materials, ancillary materials, and starting materials is, unfortunately, riddled with as many inconsistencies as the spelling in spam emails. That’s why I was a big fan of this brief article from Voisin Consulting Life Sciences which puts USP and European Pharmacopeia/EMA material definitions all in one place. (There’s a part 2 on starting materials forthcoming!)
- In the past few weeks, there’s seemingly been a rush to build greater plasmid DNA capability across the CGT/RNA industry — which makes the good folks at Fairfield Market Research veritable fortune tellers for penning their recent article, “Plasmid DNA Manufacturing to See Impressive Growth In Years Ahead.”
- Because we’re still waiting for an email with the subject line, “Got endonuclease release criteria?” BioPhorum has released a white paper advocating for a harmonized testing and release framework for endonucleases (and, hopefully, a future with more targeted/endonuclease-specific compendial standards).
- Please note: Materials used in mRNA product manufacturing (i.e., RNase, DNAse) & sequence-specific endonucleases (e.g., CRISPR CAS-9 and restriction enzymes) are excluded from the scope of this whitepaper.
MAILER DAEMON: Undelivered mail returned to sender
- This may not be spam — but it is a terrible LNP (ex-hepatic) delivery joke.
- Over the past few weeks/months, I’ve been collecting a wide array of materials on everyone’s favorite nonviral delivery vehicle. Whether it be formulation-, cryopreservation-, or R&D/process development-oriented, there’s something here for everyone.
Pills for Potency. Fast Delivery!
[PET GENE THERAPY]
- Why yes, I have gotten this email before — and yes, I did request it.
- Researchers recently published a study in Nature revealing that an AAV gene therapy has kept female cats kitten-free for two years.