BioPharm International, December 2010 - BioPharm International

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BioPharm International, December 2010
Features
Safe Freeze–Thaw of Protein Drug Products: A QbD Approach
By Xavier Le Saout , Eric Youssef , Hervé Broly , Matteo D. Costioli
Apply a DoE strategy to test several formulations in parallel.
Managing Raw Materials in the QbD Paradigm, Part 2: Risk Assessment and Communication
By Anurag S. Rathore, PhD , Duncan Low
Evaluate and communicate risk to stakeholders.
Getting Better at Making Stuff
By Chris Driscoll
To achieve manufacturing excellence, biopharma companies must adopt four key operating principles.
From the Editor
New Adventures
By Laura Bush
Biotech, and bioprocessing more specifically, is a great place to be. But it's time for a new adventure.
Regulatory Beat
Biotech Manufacturers Face New Political Landscape
By Jill Wechsler
Changes on Capital Hill create uncertainty for healthcare reform, drug regulation, and biomedical research.
Outsourcing Insights
Winning Big
By Jim Miller
Covance's deal with Sanofi-Aventis demonstrates the power of scale and scope.
Disposables Advisor
Implementing Disposables Technology, Delivering Innovation, and Transforming an Organization
By Andrew Sinclair , Miriam Monge
Sanofi Pasteur's disposables implementation plan is part of a larger evaluation of technology innovation. Here's how they approach it.
Final Word
Public–Private Partnerships: Life-Saving Mechanisms of Action
By Art Canter , Jan Twombly
Managing partnerships for the greater good.

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