BioPharm International, March 2011 Issue (PDF)
PDA’s New Technical Report for Biotech Cleaning Validation
Quality by Design: The Case for Change
Executive management leadership is essential in the effective implementation of QbD.
First-Hand Look at India's Pharma Services Sector
Indian manufacturers are not now a threat to Western CMOs, but may be long term.
Industrialized Production of Human iPSC-Derived Cardiomyocytes for Use in Drug Discovery and Toxicity Testing
The authors describe an industrialized process for the manufacture of iPSC-derived human cardiomyocytes.
Change and Innovation
BioPharm International is the longest-running peer-reviewed publication dedicated to your work.
USP Product-Class Standards for Biologics
US Pharmacopeia develops and improves its class approach for ensuring quality biopharmaceuticals.
How Multipurpose is a Disposable Bioreactor?
The authors discuss the use of single-use bioreactors.
Demonstrating Comparability of Stability Profiles Using Statistical Equivalence Testing
The authors present an approach for testing statistical equivalence of two stability profiles.
PDA's New Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
Drug Safety and Shortages Challenge Manufacturers
As drug shortages make headlines, FDA tests the Sentinel safety system and its effect on healthcare.
Risk-Analysis Tools in Process Validation of Biopharmaceutical Drugs
The authors review risk-assessment tools to evaluate product quality.
