04.21.14 -- FDA Develops New Potency Assay For Flu Vaccines; J&J Signs Up As First Partner In Drug Discovery Initiative
ScreenFect™ A is a transfection reagent composed of new cationic lipids. It is applicable to cell lines from various eukaryotic species and can be added directly to media containing antibiotics and sera. It works with DNA and siRNA and can show highly efficient transfection in common cell lines, stem cells, blood cells, microglia and primary culture cells. Because of low toxicity, media changes after transfection are not required. Learn more.
By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.
Quality management is an increasingly important focus for biopharmaceutical manufacturers looking to avoid production problems and failures. And it’s increasingly becoming a multifaceted, industrywide concern as regulators take a closer look. With this in mind, it’s useful to see how the industry is approaching quality management in terms of the initiatives being pursued.
By Sophie Koenig, Biopharma Technology Limited
Freeze drying is done to enable long-term storage. Water affects many products both chemically and physically, therefore, removing the moisture stabilizes the product so that its immunologic potency, viability, and integrity are not compromised.
By Claudia M. Hüther-Franken, Helmut Kewes, and Dr. Michael Schomberg
CEVEC has established a master cell bank (MCB) of CAP cells growing in suspension, tested and certified according to ICH guidelines and European Pharmacopeia. Simple and reliable protocols allow for the fast generation of customized producer cell lines for pharmaceutically relevant proteins based on the parental permanent CAP cells under controlled and optimized conditions.
By Nick Hutchinson, Market Development Manager, Parker domnick hunter Process Filtration
The scale-up and transfer of manufacturing processes is common during the life cycle of biopharmaceutical molecules.