BioPharm International Supplements, March 2011 - BioPharm International

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BioPharm International Supplements, March 2011
Articles
Sponsor-CMO Conflict Management for Clinical-Phase Biologics
By Pierre Douette , Philippe Ledent , Sophie LePage , Pascal Bolon
The authors present the CMO's perspective on various potential sources of sponsor-CMO conflicts.
Successful Technology Transfer, Process Validation, and Partnership with a CMO
By Sushil Abraham , Howard Bland
The authors present lessons learned from a case study of the transfer of a cell culture biotherapeutic process to a CMO.
Key Considerations When Outsourcing Cell-Culture Medium Development
By Trent Carrier , Steve Gorfien , Brian Griffith
The authors examine several issues that will help streamline negotiations between a service provider and a cell-culture medium consumer.
Supply-Chain Transformation: Strategic Necessity for the Life Sciences
By Carla Reed
New supply-chain challenges are forcing companies to act in different ways to secure product safety.

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