BioPharm International, March 2010 - BioPharm International

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BioPharm International, March 2010
Features
Characterizing the Formulation Design Space
By Adeola O. Grillo, PhD , Martin Kane , Neçois Penn , Melissa Perkins, PhD
Design of experiments is a valuable tool for identifying aspects of a formulation that are critical to product quality.
The Role of Process History in Establishing Clear Technology Transfer Criteria
By Michael Glacken
Sufficient process history is key to the rapid transfer of your process.
Mathematical Programming for the Design and Analysis of a Biologics Facility-Part 2
By Donald L. Miller , Derrick Schertz , Christopher Stevens , Joseph F. Pekny
An algorithmic approach to fine tune facility design and predict capacity.
Regulatory Beat
Corrective and Preventative Action Programs: A Mechanism of Control
By Kathleen Hodges
An effective CAPA plan provides a mechanism for responding to the unexpected.
FDA Seeks More Timely Drug Information Electronically
By Jill Wechsler
The new Sentinel system aims to expand access to data on medical product safety and patient effects.
Final Word
Quality Considerations for Peptide Manufacturing Processes
By Shawn Shirzadi
As a key element in the peptide production process, quality should be built into every step.
Downstream Trends
Downstream Processing: Promising Technologies are on the Horizon
By Eric S. Langer
The new technologies being developed to improve downstream systems go beyond traditional chromatography.
From the Editor
Lessons from the War on Terrorism
By Laura Bush
Sharing information is a critical part of security—whether we're protecting travelers from bombs or patients from adulterated medicines.
Perspectives on Outsourcing
India's Future as a Biologics Manufacturing Hub
By Karen Politis Virk
Collaborations between Western and Indian companies may provide the best path for offshoring successfully and for developing India's readiness.

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