BioPharm International, January 2010 Issue (PDF)
Biopharma Navigates Stormy Seas
Quality by Design and Compliance Readiness
How will implementing Quality by Design strategies affect your compliance status?
Issues and Opportunities Challenge Biotech Manufacturers
Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.
Supplier Quality Management: A Risk-Based Approach
A systematic classification system makes supplier quality management feasible, even if you are dealing with hundreds of suppliers worldwide.
QbD: A Roadmap to Adoption
The nimbleness of biotechs makes them well suited to implementing QbD. Here's how to get started.
Biotech in Good Shape for 2010
The companies that have survived the financial meltdown are well placed to adapt to the new environment that we now are entering.
Quality by Design for Biotechnology Products—Part 3
Regulatory flexibility can make continuous improvement possible.
Can Biopharma Steer Through the Stormy Seas?
The year 2009 was marked by recession, industry megamergers, and venture-capital scarcity. How did biopharmaceutical professionals fare?
Regulatory Relief: An Idea Whose Time Has Come
QbD has always embraced the notion that companies could make certain process changes without regulatory oversight.
Setting Specifications for a Biotech Therapeutic Product in the Quality by Design Paradigm
Key considerations for defining your overall control strategy.