BioPharm International, March 2011 - BioPharm International

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BioPharm International, March 2011
Features
PDA's New Technical Report for Biotech Cleaning Validation
By Anurag S. Rathore , Destin A. LeBlanc
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.
Demonstrating Comparability of Stability Profiles Using Statistical Equivalence Testing
By Leslie Sidor , Rick Burdick , Darrin Cowley , Brent S. Kendrick, PhD
The authors present an approach for testing statistical equivalence of two stability profiles.
How Multipurpose is a Disposable Bioreactor?
By Nico M.G. Oosterhuis , Hans J. van den Berg
The authors discuss the use of single-use bioreactors.
Industrialized Production of Human iPSC-Derived Cardiomyocytes for Use in Drug Discovery and Toxicity Testing
By Blake Anson , Emile Nuwaysir , Wen Bo Wang , Brad Swanson
The authors describe an industrialized process for the manufacture of iPSC-derived human cardiomyocytes.
From the Publisher
Change and Innovation
By Allen Basis
BioPharm International is the longest-running peer-reviewed publication dedicated to your work.
Regulatory Beat
Drug Safety and Shortages Challenge Manufacturers
By Jill Wechsler
As drug shortages make headlines, FDA tests the Sentinel safety system and its effect on healthcare.
Compliance Notes
Quality by Design: The Case for Change
By James P. Catania
Executive management leadership is essential in the effective implementation of QbD.
Outsourcing Insights
First-Hand Look at India's Pharma Services Sector
By Jim Miller
Indian manufacturers are not now a threat to Western CMOs, but may be long term.
Final Word
USP Product-Class Standards for Biologics
By Tina S. Morris, PhD
US Pharmacopeia develops and improves its class approach for ensuring quality biopharmaceuticals.

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