BioPharm International, August 2011 - BioPharm International

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BioPharm International, August 2011
Features
Top 1000 Global Biomanufacturing Facilities
By Eric S. Langer
Insights from real-time ranking of global biomanufacturing capabilities.
Efficient Multiproduct Process Development Case Study
By Zahra Shahrokh , Stacy Price , Marcio Voloch
Achieving multiproduct development within shortened timelines.
Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug Substances
By Simon Chalk , Scott Probst , Paul Gil , Tim Palberg , Matt Kennedy , Joe Rogalewicz , Jeff Johnson , Ken Green
The authors re-examine environmental controls in the context of technical advances in manufacturing.
From the Editor
Biosimilars or Bust
By Michelle Hoffman
Are biosimilars the next big thing or just the next big bubble?
Regulatory Beat
FDA Maps Strategy to Counter Supply-Chain Threats
By Jill Wechsler
Rising imports, overseas production spur collaboration and realignment of enforcement activities.
Disposables Advisor
Particulate Quality of Single-Use Filling Systems
By Jerold Martin
The author looks at strategies to minimize particle levels in the finished product when using single-use technologies downstream of final capabilities.
Perspectives on Outsourcing
Offshoring Biomanufacturing
By Eric S. Langer
China rises to the top as a destination for international outsourcing.
USP Insights
Developing an International Dialogue on Biologics Standards
By Tina S. Morris, PhD
US Pharmacopeia promotes horizontal standards and a product-class approach for quality attributes.
Final Word
Biopharmaceutical High Performance
By Michael Brueckner , David Sheehy
Industry may be its own obstacle to success in achieving the desired high-performance state.

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