Wednesday, June 23, 2021 Daily Archives

The Importance of Real-Time CO2 Monitoring in Cell Culture

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This webcast features: Oliver Berteau, Pharmaceutical & Biotech Industry Manager, METTLER TOLEDO Process Analytics Inline dissolved CO2 (dCO2) measurement and monitoring during cell culture offers significant benefits for process control impacting productivity and quality attributes. Real-time dCO2 measurement complements routine dissolved CO2 measurements with a blood gas analyzer (BGA) during preclinical and commercial operations. Animal and insect cells are more or less sensitive to the level of dCO2 during cell culture. Toxic below and beyond specific thresholds, dCO2 is also…

June 23, 2021

Contractor Perspectives: Best Practices for Transfer, Handling, Testing, and Storage of Cell Banks

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For comments about how contract development and manufacturing organizations (CDMOs) manage their cell-banking quality assurance (QA) practices. I contacted long-time member of BPI’s Editorial Advisory Board Scott M. Wheelwright, PhD, for his perspectives. Wheelwright brings many years of experience to this discussion, with insights into the evolution of technologies and practices extending back to the early launch of the biopharmaceutical industry. Currently, he provides consulting support for companies with manufacturing and sourcing in China and other Asian countries. He also…

June 23, 2021

AM-Pharma expands KBI partnership for kidney disease candidate

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The agreement will advance AM-Pharma’s recAP program towards commercialization with KBI providing drug substance manufacturing and regulatory support. AM-Pharma’s recombinant human Alkaline Phosphatase (recAP) program is a potential treatment for Sepsis-Associated Acute Kidney Injury (SA-AKI). Acute kidney disease affects hundreds of thousands of people globally and currently has no authorized pharmacological treatments. Both firms partnered in 2011 to develop the program, which saw contract development manufacturing organization (CDMO) KBI Biopharma provide initial process development and manufacturing for early clinical use.…

June 23, 2021

Repligen buys French filtration firm Polymem

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Repligen Corporation has continued its M&A spree with the acquisition of hollow fiber technology firm Polymem. The deal, once complete, will see Repligen add Toulouse, France based ultra and microfiltration tech firm Polymem to its bioprocess portfolio. Polymem was established in 1997 by two engineers specializing in hollow fiber membrane manufacturing and has built itself up into a firm servicing numerous industries, including the biomanufacturing sector. “The acquisition significantly expands our hollow fiber membrane and module production capabilities and adds…

June 23, 2021

ViiV to get under the skin of HIV through $40m Halozyme deal

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Halozyme’s ENHANZE drug delivery technology gives ViiV Healthcare more “shots on goal†to develop ultra-long acting drugs against HIV, the firm says. ViiV Healthcare, owned by GlaxoSmithKline (GSK) with investments from Pfizer and Shionogi, paid Halozyme Therapeutics $40 million upfront this week to use the latter’s ENHANZE drug delivery technology across several candidates targeting HIV. Halozyme could receive up to $175 million in development and commercial milestones per target. “The four specific HIV medicine targets will expand opportunities for development…

June 23, 2021