Navigating Emerging Markets: South Korea
The bio-pharmaceutical business outlook in South Korea remains positive
New Gene Patent Rules
The US Supreme Court's Myriad decision satisfied both patient groups and patent holders
Filling a Drug Safety Gap
As the Supreme Court ruled on generic-drug liability, FDA outlined new rules for warning labels.
Process Lifecycle Validation: Applying Risk Management
The authors discuss the application of risk management in process lifecycle validation, manufacturing, and change control.
Bioprocessing Advances in Vaccine Manufacture
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
Applying Continuous-Flow Pasteurization and Sterilization Processes
The author discusses HTST pasteurization and UHT sterilization.
Seeking Harmonization in Nanomedicines Regulatory Framework
Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.
Pharma Invests in Gene Therapy Programs
Pharmaceutical companies have stepped up gene therapy development in the wake of the approval of Glybera in 2012.
Making Connections: The Crucial Junctions in Single-use Systems
Choosing the right disposable components for your application.
India Braces for New Drug Pricing Policy
Industry players brace themselves to face challenges as India's new drug-pricing policy kicks in full gear.
Generic Drugs Face Regulatory and Scientific Challenges
FDA funds research to further development of innovative generics, while working to address review and approval issues.
Clearing Viral Concerns in Animal-Derived Biomaterials
Viruses in animal-derived starting materials could contaminate biopharmaceutical final product. A rigorous testing strategy and removal methods are reviewed.
BioPharm International, August 2013 Issue (PDF)
Click the title above to open the BioPharm International August 2013 issue in an interactive PDF format.
