New York, NY (PRWEB) October 31, 2013
BioProcess International announces the publication of the BioProcess International October 2013 issue featuring the following articles and special reports:
Focus on Purification
Membrane adsorbers are the fastest-growing segment of single-use bioprocessing. But in this article, Eric Langer reports on results from the latest BioPlan Associates survey on biopharmaceutical manufacturing showing that membrane adsorbers are still among the least-adopted disposable devices. With input from makers and users, he addresses the question of how and whether such technology can revolutionize bioprocessing.
Focus on the Regs
In 2013, the European Medicines Agency (EMA) issued two guidance documents addressing production and quality control using bovine serum and porcine trypsin. In this article, Martin Wisher’s first installment of a quarterly regulatory series looks at key points of those new guidances, which define expected approaches for minimizing the risk of virus contamination when using such animal-derived raw materials.
Focus on Outsourcing
Biopharmaceuticals present much opportunity to contract manufacturers. But they must harmonize and seamlessly integrate their quality systems with regulatory requirements and client expectations. In this article, three authors from Kemwell Biopharma describe structural and manufacturing complexities, quality challenges, regulatory concerns, and strategies for meeting requirements of clients around the globe.
BPI Lab: Cell Signaling
Cell signaling and signal transduction allow cells to perceive and correctly respond to their environment. Understanding cellular communication is vital to bioengineering and disease treatment. In this article, senior technical editor Cheryl Scott explores some history, commonly used analytical methods, and reasons for studying cell signaling in biopharmaceutical developm
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