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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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By Kimberly Benton, Dark Horse Consulting Group | Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance. Let's explore with a former FDA/CBER regulator. |
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By Antony Hitchcock, principal and owner, AGH Bioconsulting | This article will consider the time and broad-based steps it takes to bring novel drugs to market and offer a new way of thinking about manufacturing development and timelines, which, for some, may fly in the face of established ways of doing things. |
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Explore two functional areas that Advancing RNA panelists consider most essential to telling an RNA product’s “story” thoroughly to regulators. |
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By Louis Garguilo, Chief Editor, Outsourced Pharma | Don’t panic if you aren’t familiar with the above acronym, which stands for Quality Management Maturity. Outsourced Pharma's Louis Garguilo wasn't – until schooled by Jason Kerr, Regulatory Intelligence Senior Manager, Moderna and Adjunct Professor of Quality Systems, Keck Graduate Institute. QMM, it appears, may very well be in your future. |
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| The Heroes Of Vaccine Development: Lipid Nanoparticles | White Paper | By Michael Nguyen, Ph.D., Helix Biotech | Lipid nanoparticles (LNPs) have played a crucial role in COVID-19 vaccine development as efficient mRNA delivery systems, exhibiting versatility and effectiveness in accelerating the process. |
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| PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2024 | The premier event on pre-filled syringes and injection devices brings together key field players to discuss the breakthroughs that are propelling the industry forward. A comprehensive agenda covers critical topics, including sustainability, large-volume injections, digital health, and regulatory compliance. Additionally, the exhibit hall featuring 120+ exhibitors, poster presentations, lightning sessions, lively Q&As, networking activities, and Drug Delivery Innovation Awards make this event a must-attend. |
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