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BioPharm International, November 2012

Features EU Sets Guidelines for Biosimilar mAbs By Sean Milmo The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on mAbs. Considerations for Scale-Up of Stem-Cell Cultures By Matthieu Egloff , Jose Castillo, PhD Scaling up stem-cell cultures requires careful consideration of the bioreactor design. Evaluation of Single-Use Fluidized Bed Centrifuge System for Mammalian Cell Harvesting By Hsu-Feng Ko , Ravi Bhatia This article discusses the evaluation of a novel single-use fluidized bed centrifuge for harvesting of antibodies. A 25-Year Retrospective on Protein Recovery through Membrane Filters By Jerold Martin This month, Jerold Martin of Pall Life Sciences takes a look at protein recovery through direct-flow microporous membrane filters over the past 25 years. From the Editor Knowledge is Power By Angie Drakulich Global coordination tactics that incorporate online technologies and social media are reshaping disease prevention and response. Global Reports Discovery Pipeline: Improved Delivery of RNA Vaccines By Amy Ritter, PhD Creating an effective nucleic acid-based vaccine requires protecting the fragile nucleic acid from degradation, effective transfection of the targeted cells, and producing high enough levels of antigen to evoke a robust immune response. Report from Turkey By Sean Milmo The government of Turkey is drawing up a program in coordination with the pharmaceutical industry to create ways to make the country a regional production center for pharmaceuticals serving Europe, Central Asia, and the Middle East. Regulatory Beat Product Analysis Key to Biosimilar Development By Jill Wechsler Manufacturing and in-depth characterization provide basis for demonstrating product equivalence. Perspectives on Outsourcing Creating a Holistic Procurement System By Gregg Brandyberry The procurement organization rethinks sourcing for maximum efficiency and results. Compliance Notes Connecting QbD, Knowledge Management, and Supplier Quality Management By J. Paul Catania Understanding overall supplier capability versus the critical-to-quality attributes of your product can reduce both risk and cost. Disposables Advisor It's an Election Year.... Are You Making the Best Choices in Single-Use Tubing By Jerold Martin The author considers the types of tubing available to the industry and how to make an informed selection. Boot Camp Technical Guide Product Characterization: A Primer NIBRT's Jayne Telford provides an overview of biopharmaceutical analytics and their accompanying qualification and validation steps. Boot Camp Business Guide Stability in Biopharmaceutical Storage Patrick Jackson of Vindon Scientific offers key considerations for choosing an outsourced sample storage facility. Bioanalytical Best Practices Assay Development and Method Validation Essentials By Thomas A. Little, PhD A 10-step systematic approach to analytical method development and validation can improve the quality of drug development. Manufacturing Best Practices The Transformation to Process-Centered Organization By Simon Chalk Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block? Final Word How to Manage Effective Leadership when Change is the Only Constant By Tracy Thurkow , Karen Gorman , Paula Butte A disciplined approach to changing behavior can achieve change agility.

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