BioPharm International, July 2013 - BioPharm International

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BioPharm International, July 2013
Features
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
By Clinton Weber , Ashok Kumar , Roland Ashton , Lisa Joslin , James Schmid , Michael Larson
Traditional project decision-making vs. a QbD approach.
Kinetic Analysis of Antibodies from Different Cultured Media
By David Ho , Tom Fletcher , Jessie H.T. Ni, PhD
An analytical method assesses the effects of media condition on cultured antibodies.
QbD and PAT in Upstream and Downstream Processing
By Susan Haigney
Industry experts discuss the implementation of QbD and PAT tools in biopharmaceutical manufacturing.
Regulatory Beat
FDA Urges Greater Focus on Contractor Quality
By Jill Wechsler
Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.
European Beat
EU Battles Medicine Shortages
By Sean Milmo
European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.
Global News
Report from Brazil
By Hellen Berger
Brazil offers opportunities and challenges for global pharmaceutical companies.
Perspectives on Outsourcing
What Happened to Outsourcing in Asia?
By Eric S. Langer
The industry may not be ready for India and China as regulatory issues emerge.
Burrill on Biotech
IPO Market Heats Up for Life-Sciences Companies
By G. Steven Burrill
Biotech companies raise most money in 13 years.
Analytical Best Practices
Essentials in Stability Analysis and Expiry Determination
By Thomas A. Little, PhD
The author discusses the need for stability analysis.
From the Editor
The Pains of Change
By Rita Peters
Pharma and biotech companies, with the rest of the healthcare industry, must face change.
Boot Camp Business Guide
Outsourced Training: A Primer
By Erkki Goodwin, CAPM
Five key attributes to look for in a biopharm training partner.

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