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 development.
Challenging Protein A
Financial opportunities are driving many technology developers to try replacing protein A, but users are growing less motivated to implement alternatives that offer only incremental improvements. For an alternative technology to seriously challenge protein A’s dominance in the antibody-purification market, simple replacement will not be enough. As Pete Gagnon describes, it will need to offer a true paradigm shift. And a few such candidates are now emerging.
New Approaches to Process Validation
The new process validation guidance asks companies in the United States and Europe to adopt life-cycle approaches — beyond the traditional three-to-five lots run at the center point of proposed ranges for operating parameters. In this article, a consensus paper from the January 2013 CMC Strategy Forum addresses how companies can leverage product design and process development information to facilitate adapting the Quality by Design paradigm more closely — allowing for a science- and risk-based selection of critical process parameters, key process indicators, and appropriate specification criteria.
Also published this month as part of the BioProcess International Supplement Series - Vaccines: New Tools and Technologies for an Expanding Industry
Also Available Online-only in the BPI Extra section of BioProcessintl.com:
Ask the Expert: The Future of Protein A
BPI’s managing editor Maribel Rios talked with Karol Lacki (staff scientist at GE Healthcare Biosciences) about the use and future of protein A in bioprocessing. Its selectivity, robustness, and well-known ability to bind to a wide range of IgG molecules have made protein A a widely accepted affinity resin for current purification streams. Nonetheless, the industry has raised some concerns over cost, productivity, and other issues. That has led to the development of novel alternatives for purification that reportedly offer advantages over protein A. Lacki discuses the impact of those systems, pointing out their specific disadvantages that should be taken under consideration. In addition, he argues that the cost of protein A may be “misrepresented.” Finally, Lacki believes “smart engineering approaches” to the use of resins will be the next trend in efficient chomatography.
Best of BPI - Revisted: Virological Safety of Biopharmaceuticals
In an audiocast with managing editor Maribel Rios, Hazel Aranha (manager of viral clearance and safety at Catalent Pharma Solutions) discusses risk assessment and management strategies since her November 2005 article, “Virological Safety of Biopharmaceuticals.” Several factors have made risk an increasingly important issue, including the globalization of the industry and concerns over emerging viruses. Some strategies for addressing risk — such as the “as low as is reasonably practicable” (ALARP) approach and conducting a cost–benefit and decision analysis — are still appropriate. ICH has developed risk-related documents, including Q9, Q10, and Q11. Aranha discusses the effects of those guidelines on risk mitigation. She also talks about how increased collaboration between industry and regulatory groups and between industry and suppliers will be a major part of the bioprocessing industry in the next five years.
View the latest issue of BioProcess International online at: http://bit.ly/16qcCRD
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About BioProcess International
BioProcess International™ (http://www.bioprocessintl.com) is a monthly, controlled-circulation magazine devoted to the development, scale-up, and manufacture of biotherapeutics and biodiagnostics. Each issue provides the global industrial biotherapeutic community with up-to-date, peer-reviewed information detailing the business, politics, ethics, applications, products, and services required to successfully drive biopharmaceuticals, vaccines, and biodiagnostics through the development and manufacturing process.
BioProcess International™ is part of the IBC Life Sciences Division of Informa, plc, a leading international provider of specialist information and services for the academic, professional and business communities. Informa offers a world-class portfolio of publications, events and data services for researchers, students, lecturers and professionals in the academic and scientific communities worldwide.