BioPharm International Supplements, March 2012 - BioPharm International

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BioPharm International Supplements, March 2012
Features
Biopharmaceutical Outsourcing Trends: The Next Decade
By Eric S. Langer
New outsourcing industry sectors have become multibillion-dollar industries.
Considerations in Biopharmaceutical Outsourcing
By Erik Greb , Amy Ritter, PhD
Because of the complexity of the manufacturing processes for biologics, transfer of these processes to a contract manufacturer presents challenges.
Meeting Challenges in Contract R&D
By Angie Drakulich
Representatives from leading CROs weigh in on key challenges tied to the biopharmaceutical R&D, including issues regarding bioequivalence, platform technologies, process analytics, and more.
Biotherapeutics Outpace Conventional Therapies
By Victor Coker
Growth in infrastructure and process-development capabilities will be required to support the biologics market.
Empire State Drug Development
By Peter Soelkner
An architectural wonder teaches the biopharmaceutical industry a valuable lesson in project management.
Key Considerations for Development and Production of Vaccine Products
By Anurag S. Rathore , Suresh Jadhav , Mahesh Bhalghat , Shiraz Kandawalla , Suma Ray, PhD , Ashok Kumar Patra
Challenges of vaccine development include regulatory, technical, and manufacturing hurdles in translating a vaccine candidate into a commercial product.
Smart Outsourcing: Strategic Alignment, Risk Management, and New Relationships
By William Schmidt , Ian Uydess
Outsourcing in the pharmaceutical industry, until recently, has been largely confined to commercial manufacturing, packaging, and support for clinical trials.
Managing the Quality Relationship for a Contractual Agreement: A CMO Perspective
By Susan J. Schniepp
The author describes an equation that can be used to define the Quality relationship between a contract manufacturing organization and a client, including how to factor in both party's needs and regulatory commitments.

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