BioPharm International, April 2013 - BioPharm International

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BioPharm International, April 2013
Features
Growth Kinetics of Human Mesenchymal Stem Cells in a 3-L Single-Use, Stirred-Tank Bioreactor
By Donghui Jing, PhD , Neethu Sunil , Sandhya Punreddy , Manjula Aysola, PhD , Daniel Kehoe, PhD , Julie Murrel, PhD , Martha Rook, PhD , Knut Niss, PhD
The authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.
Milestones and Moderate Progress in 2012 Drug Approvals
By Gary Walsh, PhD
First gene therapy and plant-based expression vector products approved in 2012.
Navigating Emerging Markets — Latin America
Latin America's diverse growing market seeks regulatory harmonization.
Regulatory Beat
Manufacturers Under Pressure to Manage Painkillers
By Jill Wechsler
Opioid abuse generates calls for efforts to curb distribution.
European Beat
Advancing QbD in the EU
By Sean Milmo
EU authorities are stepping up their efforts to incorporate QbD principles.
Global Reports
Report from Thailand
By Jane Wan
The Thai government is ramping up efforts to promote and develop the biotechnology sector in a bid to enhance its global competitiveness.
Burrill on Biotech
Financing Innovation
By G. Steven Burrill
Early-stage companies are finding alternatives to venture capital.
Manufacturing Best Practices
Benchmarking: Don't Just Run the Numbers, Understand the Process
By Simon Chalk
Benchmarking can be a useful tool to improve manufacturing practices.
Compliance Notes
State of Quality and Compliance in the Biopharmaceutical Industry
By Anastasia G. Lolas , Ian Uydess
Have FDA initiatives improved manufacturing quality?
Boot Camp Tech Guide
ZFN Technology Advances Biopharmaceutical Manufacturing
By Kate Achtien
Applications of ZFN technology in biopharmaceutical cell-line engineering.
Perspectives on Outsourcing
Strategic Partnering for Manufacturing
By Jim Miller
An innovative approach to capacity management.
Guest Editorial
Prescribing Caution for Biosimilars
By James C. Greenwood
Sound policies are needed to govern the substitution of interchangeable biologics.

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