BioPharm International, February 2012 - BioPharm International

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BioPharm International, February 2012
Features
The Challenges of Emerging Markets
By Bikash Chatterjee
The difficulties of doing business in China are offset by its adoption of more stringent GMP standards.
Preparing For the New China
By Jon Zifferblatt
China's healthcare reforms generate uncertainty for its domestic pharmaceutical market.
What the 2011 Census of India Reveals for Pharma
By Mangeshi Sai
The census reveals the state of the population of India's health and the potential for growth in the healthcare market.
Trends and Challenges in Biologics Outsourcing: A Q&A with Stephen Taylor
Stephen Taylor PhD, vice-president and commercial director at Fujifilm Diosynth Biotechnologies, addresses some of the challenges facing biologics outsourcing.
Assessing the Risk of Leachables from Single-Use Systems
By Paul F. Killian
This article is the second in a two-part series on extractables and leachables.
A Risk-Based Approach to Transferring a Mature Biopharmaceutical Process
By Jean Harms , Purav Dave
Strategies for transfer of the manufacturing process.
PQRI Case Study: Facility Biocontainment and Inactivation
By Steve Reich , Kristin Murray , Ted Frank , Stephen Brooks , Ed Sanchez , Brian Hasselbalch , Kwame Obeng , Richard Creekmore
A Risk-Management Case Study.
A 25-Year Retrospective on Mammalian Cell Culture
This month, we revisit "Industrial-Scale Mammalian Cell Culture, Part I: Bioreactor Design Considerations."
From the Editor
Sustainable Investment
By Angie Drakulich
Industry announces plans for year ahead at annual JPMorgan Global Healthcare Conference.
Regulatory Beat
FDA and Justice Department Address Drug Quality Concerns
By Jill Wechsler
More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.
Perspectives on Outsourcing
Biomanufacturing Outsourcing Outlook
By Eric S. Langer
Industry optimism is on the rise for 2012.
Disposables Advisor
Understanding Gamma Sterilization
By Jerold Martin
This article outlines methods, validation standards, and documentation of sterilization of single-use products using gamma irradiation.
Manufacturing Best Practices
The Drive for Best Practice in Biopharmaceutical Manufacturing
By Simon Chalk
Introducing a new way to think about sharing information in a patent-driven industry.
Final Word
Saving the Next Generation of Regulatory Scientists
By Frances J. Richmond
New educational programs are key to the industry's future and to safe, available drugs.

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