BioPharm International, August 2013 - BioPharm International

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BioPharm International, August 2013
Features
New Gene Patent Rules
By Antoinette Konski
The US Supreme Court's Myriad decision satisfied both patient groups and patent holders
Pharma Invests in Gene Therapy Programs
Pharmaceutical companies have stepped up gene therapy development in the wake of the approval of Glybera in 2012.
Applying Continuous-Flow Pasteurization and Sterilization Processes
By John Miles
The author discusses HTST pasteurization and UHT sterilization.
Navigating Emerging Markets: South Korea
By Jill E. Sackman, PhD
The bio-pharmaceutical business outlook in South Korea remains positive
Process Lifecycle Validation: Applying Risk Management
By Anurag S. Rathore, PhD , Scott Bozzone , A. Hamid Mollah
The authors discuss the application of risk management in process lifecycle validation, manufacturing, and change control.
Regulatory Beat
Generic Drugs Face Regulatory and Scientific Challenges
By Jill Wechsler
FDA funds research to further development of innovative generics, while working to address review and approval issues.
European Beat
Seeking Harmonization in Nanomedicines Regulatory Framework
By Sean Milmo
Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.
Perspectives on Outsourcing
Bioprocessing Advances in Vaccine Manufacture
By Eric S. Langer , Ronald A. Rader
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
Disposables Advisor
Making Connections: The Crucial Junctions in Single-use Systems
By Jerold Martin
Choosing the right disposable components for your application.
Boot Camp Technical Guide
Clearing Viral Concerns in Animal-Derived Biomaterials
By Kate Smith
Viruses in animal-derived starting materials could contaminate biopharmaceutical final product. A rigorous testing strategy and removal methods are reviewed.
Global Feature
Report from India
By Jane Wan
Industry players brace themselves to face challenges as India's new drug-pricing policy kicks in full gear.
From the Editor
Filling a Drug Safety Gap
By Rita Peters
As the Supreme Court ruled on generic-drug liability, FDA outlined new rules for warning labels.

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