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By AR Welch, Editorial & Community Director, Advancing RNA | Bushwacking up a trailless mountain — as many of us may feel we’re doing today with the development of our mRNA therapeutics — is bound to be accompanied by its fair share of drama. These dynamics became increasingly apparent to me as I listened to a presentation unpacking the results of a BioPhorum benchmarking survey on CPPs for plasmid linearization, mRNA drug substance, and mRNA drug product production. |
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Three regulatory experts share the topics on which they hope to see further agency clarification in the near-term to help mRNA products make meaningful progress toward/through the clinic. |
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By Jie Huang, M.D./Ph.D., CSTEAM-Biotech | As stem cells age, their regenerative capacity declines due to accumulated genetic and epigenetic changes. Using CRISPR-Cas, scientists can directly edit these changes or modulate aging-related pathways. |
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| Addressing the most prominent pain points of speed, cost of production and limited flexibility, the mRNA Process Development & Manufacturing Summit returns to Boston this September. Hear from 30+ technical experts from the likes of Moderna, BioNTech, Sanofi and Strand Therapeutics across three days of content spanning tracks dedicated to Research Scale and IND-Enabling & Clinical Scale production. See program here. |
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| Strategies For A More Secure Outsourcing Bottom Line | Article | inSeption Group | A panel of experts from across the pharmaceutical/biopharmaceutical industry recently shared their experiences in mitigating financial risk before partnering with a contract research organization (CRO). |
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| How To Make The Best LNPs | White Paper | By Michael Nguyen, Ph.D., Helix Biotech | There are various factors that require careful consideration throughout the process of formulating LNPs and utilizing them for successful mRNA delivery and translation. |
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| A New Center For Continuous mRNA Manufacturing | Article | ReciBioPharm | Explore how a partnership between academia, regulatory agencies, and manufacturing organizations has the potential to reshape the way we produce and distribute mRNA-based therapies. |
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