BioPharm International, January 2010 - BioPharm International

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BioPharm International, January 2010
Cover
Can Biopharma Steer Through the Stormy Seas?
By Chitra Sethi
The year 2009 was marked by recession, industry megamergers, and venture-capital scarcity. How did biopharmaceutical professionals fare?
Features
Online Exclusive: Analytical Strategies for Monitoring Residual Impurities
By Jon S. Kauffman, PhD
Best methods to monitor product-related impurities throughout the production process.
Setting Specs for a Biotech Therapeutic Product in the QbD Paradigm
By Anurag S. Rathore, PhD
Key considerations for defining your overall control strategy.
Manufacturing Economics Series
Quality by Design for Biotechnology Products—Part 3
By Taruna Arora , Roger Greene , Jennifer Mercer , Paul Tsang , Meg Casais , Stuart Feldman , Jutta Look , Tony Lubiniecki , Joseph Mezzatesta , Stefanie Pluschkell , Mark Rosolowsky , Anurag S. Rathore, PhD , Mark Schenerman , Tim Schofield , Samantha Sheridan , Paul Smock , Sally Anliker , Lois Atkins , Bernerd McGarvey , Bruce Meiklejohn , Jim Precup
Regulatory flexibility can make continuous improvement possible.
Regulatory Beat
Issues and Opportunities Challenge Biotech Manufacturers
By Jill Wechsler
Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.
Quality by Design and Compliance Readiness
By Chester A. Meyers, PhD , Debra Weigl
How will implementing Quality by Design strategies affect your compliance status?
From the Editor
Regulatory Relief: An Idea Whose Time Has Come
By Laura Bush
QbD has always embraced the notion that companies could make certain process changes without regulatory oversight.
Burrill on Biotech
Biotech in Good Shape for 2010
By G. Steven Burrill
The companies that have survived the financial meltdown are well placed to adapt to the new environment that we now are entering.
Perspectives on Outsourcing
Supplier Quality Management: A Risk-Based Approach
By Bob Rhoades
A systematic classification system makes supplier quality management feasible, even if you are dealing with hundreds of suppliers worldwide.
Final Word
QbD: A Roadmap to Adoption
By Todd Hein
The nimbleness of biotechs makes them well suited to implementing QbD. Here's how to get started.

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