The FDA requires biopharmaceutical manufacturers to understand and control sources of variation according to the risks they present to process and product. Cell culture media and feeds have been shown to affect cellular performance, product quality, or both. The evolution of media formulas to those that are serum-free and chemically defined poses both a challenge and an opportunity. The challenge is identifying which of the many components have the greatest impact on cells and the molecules they produce. The opportunity…
Monday, March 23, 2020 Daily Archives
Jefferson Institute selects Gyros tech for bioprocess training
Philadelphia’s Jefferson Institute for Bioprocessing (JIB) will incorporate buffers and titer kits supplied by Gyros Protein Technologies in its training programs. JIB opened its doors in Philadelphia, Pennsylvania last June with support from Ireland’s National Institute for Bioprocessing Research and Training (NIBRT). The center has now inked a contract with immunoassay and peptide synthesis firm Gyros Protein Technologies – now part of Mesa Laboratories – to use its immunoassay system and ready-to-use kits as part of its bioprocessing training programs.…
Eppendorf expands centrifuge business with Koki buy
Eppendorf says the addition of Koki Holdings’ centrifuge business will help provide its biopharma customers a full product portfolio for centrifugation steps in clinical trial, drug discovery and production. The deal – financials of which have not been disclosed – sees German bioprocess vendor Eppendorf expand its business through the addition of Tokyo, Japan-based Koki’s ‘himac’ brand of centrifuge equipment. “A full functioning business organization, including R&D, operations, sales/service and business administration will be carved out of Koki Holdings Co., 
COVID-19: Chinese biomanufacturer CMAB returns to full operations
As doors close in Europe and the US, there is some hope in China with CMAB Biopharma returning to full operations following the COVID-19 pandemic. As the novel coronavirus (COVID-19) continues to close down normal life in Europe, there are signs that normality is beginning to return in China, the country where the outbreak was first reported. According to data from Johns Hopkins University, daily increases in coronavirus cases in China have dropped to fewer than a hundred compared to…
Danaher closes in on $21bn GE takeover after FTC approval
Danaher says the GE Biopharma takeover will complete this month after US competition authorities grant conditional approval for the $21.4 billion deal. The condition imposed by the US Federal Trade Commission (FTC) is that Danaher sells some bioprocessing technologies and products. The Commission announced its decision on March 20, explaining the original deal would have unfairly reduced competition. The divested techs will include microcarrier beads, various chromatography columns and skids, single use tangential flow filtration systems, label-fee molecular characterization instruments…