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| There’s been great progress in establishing platforms for linear mRNA vaccines — but where does this current know-how fall short for those exploring linear and next-gen RNA constructs for non-vaccine products? Secure your spot for Advancing RNA Live’s next digital panel discussion on the current known unknowns (and unknown unknowns) about our mRNA therapeutics candidates that make adopting the traditional QbD approach complicated. Registration is free thanks to the support of Roche Custom Biotech. |
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Though the mRNA industry is excited about the possibilities of the FDA’s “Platform Provision,” a recent discussion between regulators suggests differences in opinion are emerging. |
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| Novel Plasmid DNA-Encoded Poly(A) Tails For mRNA Synthesis | Poster | By L. Hinkel, N. Prugar, S. Chilton, O. McPhee, et al., Vernal Biosciences | Here, we evaluate the stability of these variant poly(A) regions and the biological activity of the mRNA containing the variant poly(A) tails made from these templates. |
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| Single-Use Technology For Quality mRNA Manufacturing | Webinar | MilliporeSigma | Learn how single-use technologies deliver important benefits for mRNA manufacturing, including increased speed, quality, flexibility, and adaptability to different dosages and scale-up strategies. |
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FEATURED EDITORIAL CONTINUED |
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By Mo Heidaran, Cellx Inc. | Lipid nanoparticles (LNPs) have generated a ton of buzz, but they pose risks that, perhaps, industry and regulators have not taken seriously enough so far. |
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By Louis Garguilo, Chief Editor, Outsourced Pharma | Jason Kerr of Moderna is a snoop, a spy, a watcher of all things. More officially, he’s tasked by his employer with monitoring for regulatory changes in the environment. “Some do call it regulatory surveillance,” he says, “Some just regulatory monitoring.” Whichever, you might need to hire a Kerr, too. Here's why. |
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| A Full-Service Solution Partner Disrupting the Outsourcing Paradigm | inSeption Group offers a full-service solution designed to disrupt the current outsourcing paradigm, resurrecting a common-sense approach to rebuild business trust and confidence in a client’s selected vendor. Primarily focused on oncology, hematology, neurodegenerative disorders, and rare/orphan disease indications, with a specialization in cell and gene therapy, inSeption has been a solution for its’ clients who have experienced the progressive degradation of today’s outsourcing options. Contact them. |
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