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The landscape of the life sciences industry is as vast and varied as the professionals who work in it. Some online resources aim to serve the entire space. We wish them luck. Instead, our goal is to be the most valuable resource for a specific segment of the industry – biotherapeutics – and the professionals who make their living there. The BioProcess Online community is not made up of generalists. They’re specialists, like us. We deliver in-depth content from authoritative authors and sources because that’s what our community demands.
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Are We Witnessing A New "Age Of The CDMO"? https://lnkd.in/eveKw86c - By Paul Cummings, PJC PHARMA CONSULTING LIMITED Across the life sciences industry, we are seeing the need for cost-effective solutions to ever more difficult development challenges that are growing in parallel with rising production costs.
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📡 When Dannielle Appelhans joined Cour Pharmaceuticals Development Co., Inc. as COO last year, the company was mostly flying under the radar. ✈️ Now she's President and CEO, and with a $105 million Series A fueling the company's growth – including two phase 2 programs, a late-stage #celiac candidate partnered with Takeda, and the internal manufacture of drug substance for its #type1diabetes candidate – the company is gaining altitude. Appelhans gave Bioprocess Online the latest here:
Embracing An Economic Model For Agile Process Development ABhttps://lnkd.in/eHU8d_G7 - By Irwin Hirsh, Q-Specialists AB Process development requires a new economic model that integrates clinical risk and lifetime product value and enables a proactive, real-time decision-making approach.
🔬"Bioprocess Pulse" November 2024 Review! 📅 Your monthly guide to the latest from Bioprocess Online. Recap top content from last month and preview upcoming webinars and events. Stay informed effortlessly! #BioprocessPulse #UpcomingEvents
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More #AI in drug discovery could put a big strain on #CMC teams who design processes to produce all those NMEs at commercial scale. Irwin Hirsh has been thinking about this issue and came up with a model that focuses on lifetime product value to bring down the cost of goods and shorten the time to market. The model takes into account: ⚠️ Clinical risk levels 👎 Failure probabilities 💸 Effects of delayed process knowledge on product lifetime value And it deploys: 👣 Queuing theory for prioritizing tasks ⏱️ Real-time access to relevant data for bench scientists A paper in JAMA earlier this year called the use of AI in #discovery "modest" and pinned the slow rollout on a short supply of clarity from regulators on what's allowed (link in comments). It's telling, however, that so many people developing AI also call for discretion and in some cases brake-pumping. This stuff is evolving fast. I think it's a matter of time before we see a surge of AI-designed NMEs. If (when) that happens, somebody will need to manufacture them.
Solving The Leukopak Supply Chain Issue With Cryopreservation https://lnkd.in/eku5dVjr - By Jennifer Chain, PhD, CABP, Ph.D., CABP, Consultant, CSM Consulting LLC This article focuses on the reliability of starting materials, particularly leukopaks, and proposes a fundamental solution to this issue.
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Join Bioprocess Online for best practices to ensure the analytical methods you're developing today are seamlessly transferrable tomorrow. Registration to this Roundtable Event is free thanks to the support of BD Biosciences. https://lnkd.in/emaVsRrb #flowcytometry #ELISA #electroporation #viraltransduction #techtransfer
Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies https://lnkd.in/exanr-FU - By Allan Marinelli and Aghijit Menon Part 3 of this series highlights key execution inconsistencies, including unnecessary deviations, poor documentation in utility verifications, and mismatched execution results with evidence records.
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If you're doing #viral inactivation and clearance in the EU for mammalian-cell-derived drug products, you probably know one of the most prolific detergents is now forbidden to use. After #TritonX100 was banned in the EU, researchers at Polymun Scientific Immunbiologische Forschung GmbH and IAVI investigated Virodex TXR-1 as a suitable alternative. They write here about their testing and what they found.