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.