12.10.21 -- Regulatory Intelligence: More Than Just Compliance
12/10/21 Pharmaceutical Online Newsletter
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12/10/21 Pharmaceutical Online Newsletter
05.13.21 -- Biopharma Cold Chain Logistics 101 Life sciences companies face major challenges to continued operations and profitability including patent expirations, low R&D productivity, increased competition, decreased margins, nonoptimized processes, and mounting compliance pressure. Join us on May 25, 2021 at 11:00 a.m. EDT, to understand the technologies needed to meet today’s requirements, how to spend more time on science and less time correcting data, and how to improve efficiencies in process development, collaboration, and product quality. ...
05.04.21 -- How To Ensure Your Quality Culture Assures Data Integrity Several biopharma startup veterans share their insight and inspiration on navigating clinical-stage regulatory considerations in this ebook. Find advice and wisdom from biopharma leaders on: Chemistry, manufacturing, and controls (CMC) considerations for first-in-human studies, Gap analysis fundamentals, And the relationship between GMP and CMC. Join Biotech Makers to network, share expertise, and get perspectives on common challenges. Collaborat...
Evonik and Cassava Sciences join forces to fight Alzheimer’s disease Evonik to supply commercial quantities of simufilam, a drug candidate for the treatment of Alzheimer’s disease The late clinical phase quantities will be produced at Evonik’s Tippecanoe site in Indiana, USA Evonik is recognized as one of the largest contract manufacturing organizations (CMO) Essen, Germany. Evonik has entered into a supply agreement with Cassava Sciences, a clinical-stage biotechnology company focused on neuroscience. Evonik will supply Cassava Sciences with large-scale, clinical-grade quantitie...
Advantages In The Continuous Manufacturing Of APIs And Intermediates Under cGMP Conditions Interview with Dr. Andreas Meudt, Head of Exclusive Synthesis, Evonik At least seven drug products utilizing continuous manufacturing processes have been approved by the FDA to-date, with many others in clinical development. However, when it comes to APIs and advanced intermediates, there are few pharmaceutical companies that have successfully utilized continuous manufacturing for more than a single process step. In addition, very few have been able to scale-up beyond the kilogram range under cGMP condi...