BioPharm International
March 01, 2011
Issue PDF
24
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PDA’s New Technical Report for Biotech Cleaning Validation
March 01, 2011
Compliance Notes
24
3
Executive management leadership is essential in the effective implementation of QbD.
March 01, 2011
Outsourcing Insights
24
3
Indian manufacturers are not now a threat to Western CMOs, but may be long term.
March 01, 2011
Features
24
3
The authors describe an industrialized process for the manufacture of iPSC-derived human cardiomyocytes.
March 01, 2011
From the Publisher
24
3
BioPharm International is the longest-running peer-reviewed publication dedicated to your work.
March 01, 2011
Final Word
24
3
US Pharmacopeia develops and improves its class approach for ensuring quality biopharmaceuticals.
March 01, 2011
Features
24
3
The authors discuss the use of single-use bioreactors.
March 01, 2011
Features
24
3
The authors present an approach for testing statistical equivalence of two stability profiles.
March 01, 2011
Features
24
3
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.
March 01, 2011
Regulatory Beat
24
3
As drug shortages make headlines, FDA tests the Sentinel safety system and its effect on healthcare.
March 01, 2011
24
3
The authors review risk-assessment tools to evaluate product quality.