Bioprocess Online

Without a doubt, this was one of the best talks I attended at the West BPI conference. Dr. Jared Dopp did a fantastic job outlining the different variables in the design space for the upstream development of glycoproteins in CHO cell lines. For a long time, it has been hypothesized that the secondary structure of a protein influences the level of glycosylation. Still, it wasn't until pretty recently that we saw evidence that supports this theory. In this talk, we learned a lot about the correlation of temperature, pH, carbohydrates, and other trace metals levelers to enhance glycosylation and the different approaches to evaluate the quality of the glycans. These are definitely exciting times for upstream development.

Without a doubt, this was one of the best talks I attended at the West BPI conference. Dr. Jared Dopp did a fantastic job outlining the different variables in the design space for the upstream development of glycoproteins in CHO cell lines. For a long time, it has been hypothesized that the secondary structure of a protein influences the level of glycosylation. Still, it wasn't until pretty recently that we saw evidence that supports this theory. In this talk, we learned a lot about the correlation of temperature, pH, carbohydrates, and other trace metals levelers to enhance glycosylation and the different approaches to evaluate the quality of the glycans. These are definitely exciting times for upstream development.

March 2025 — CDMO Opportunities And Threats Report The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections. https://lnkd.in/eqTcnwd7

Process Optimization or Full-Scale Automation? Is full-scale automation truly the future of biomanufacturing, or can process optimization and intensification deliver similar benefits with fewer capital demands? On April 22, join us for a conversation with David Bruehlmann, Ph.D., an industry leader in bioprocess innovation, CMC development, and large-scale manufacturing. As Managing Director of Brühlmann Consulting, David has helped biotech companies reduce costs, accelerate market entry, and improve manufacturing efficiency. His experience ranges from scaling 15,000-L bioreactors to developing high-throughput cell-line and media optimization strategies, giving him a unique perspective on the continuous vs. optimized debate. Don't miss this chance to gain expert insights from David and other top bioprocessing minds. Register now: https://lnkd.in/eCY-ttWf

How AI Is A Game-Changer For Auditing Compliance And Efficiency By Jesper M. Wagner and Thomas Sølver, NIRAS The number of warning letters and Form 483s issued by the FDA has increased dramatically over recent years. Between FY2021 and FY2024, there was a 161% rise in 483s for drugs and a 252% rise for medical devices.1 This indicates that quality audits are more important than ever. https://lnkd.in/efAb2spr

Process Optimization or Full-Scale Automation? As biopharma companies navigate the future of manufacturing, the debate between process optimization and full-scale automation is more relevant than ever. Join us on April 22 for an in-depth discussion featuring Irina Ramos, Ph.D., Senior Director at Johnson & Johnson Innovative Medicine. With expertise in CMC development, continuous biomanufacturing, and technology transfer, Irina has played a pivotal role in advancing manufacturing strategies—from early-stage development to commercial-scale production. Her leadership in process intensification and automation has driven efficiency across the industry, including her contributions to the AZ COVID-19 vaccine transfer. Don’t miss this chance to hear from Irina and other top experts! Register now: https://lnkd.in/ePaeCF8P

From BPI West: An Upstream Scientist's Advice On Target Glycosylation Tyler Menichiello sits down with Jared Dopp, Ph.D., senior scientist in upstream biologics development at Bristol Myers Squibb, to ask: "What key advice do you have for our readers on optimizing upstream development?" https://lnkd.in/em3XJA-5

Process Optimization or Full-Scale Automation? The debate continues! While continuous processing gets plenty of buzz, many biopharma experts argue that process optimization and intensification can deliver similar benefits—without the hefty investment in infrastructure. Join industry leaders Irina Ramos, Ph.D., Nicholas Guros, Ph.D., and David Bruehlmann, Ph.D. as they explore the scalability, sustainability, and cost implications of these two approaches. 📅 April 22, 2025 | 11:00 AM EDT Register now: https://lnkd.in/eWd-ep45

AI Model Cards Make Function And Risk Easier To Understand By Andy O' Connor, ERA Sciences Datasheets and labels are already a standard way to document warnings and limitations in pharma. Model cards apply the same logic to AI, providing a streamlined way to answer critical compliance questions. https://lnkd.in/eXXrUT54

Join Cytiva to explore the critical role of PUPSIT in quality risk management. They'll cover key risks, including IT methods, wetting, dilution, and recovery, while offering practical solutions for single-use systems. Learn about new standard filtration systems and real-world implementation examples to streamline sterile drug product filtration. #Cytiva #PUPSIT #singleusesystems