BioPharm International, November 2009 - BioPharm International

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BioPharm International, November 2009
Cover
Quality by Design for Biotechnology Products—Part 1
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 , John Towns
First in a three-part series that discusses the complexities of QbD implementation in biotech product development.
Features
To FIT or Not to FIT, That is the Question
By Katherine Chaloupka , Naveen Pathak , Sourav Kundu
Conducting a FMEA analysis is a good first step in a risk-based approach for determining the need for a filter integrity test.
Manufacturing Economics Series
Rapid Process Development for High Yield Plasmid DNA Fed-batch Fermentation
By James A. Williams , Clague P. Hodgson , Aaron E. Carnes
How to reduce plasmid-mediated metabolic burden for higher yields.
From the Editor
Where Winning is the Only Thing
By Laura Bush
What football and bioprocessing both have in common is that in both cases, success is a minimum requirement.
Regulatory Beat
Safety First in Biotech Development
By Jill Wechsler
Heightened attention to product safety issues is slowing the approval process for new therapies.
Perspectives on Outsourcing
Finding the Balance in Managing the Quality and Efficiency of the Supply Chain
By Mike Jovanis
An enterprise-wide quality management initiative is required to maintain supplier quality without sacrificing bottom-line objectives.
Compliance Notes
QbD and GMPs: How the Convergence of Science and Compliance Will Change the Way We Work
By Chester A. Meyers, PhD , Debra Weigl
The focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.

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