BioPharm International, December 2012 - BioPharm International

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BioPharm International, December 2012
Features
Job Security in a Changing Biopharma Environment
By Amy Ritter, PhD
Results from the 2012 employment survey.
Optimizing Global Biopharmaceutical Operations Through Risk Mitigation and Management
By Phil Kaminsky , Jiyang Liu , Julia Olsen-Claire
A UC Berkeley survey provides insight into biopharma's risk concerns and strategies.
Navigating Emerging Markets
By Jill E. Sackman, PhD
An introduction to a new series on manufacturing within global markets.
A New Scale-Down Membrane Adsorber Device for Process Development and Validation
By Nathalie Frau, PhD , Martin Leuthold, PhD , Amit Mehta, PhD , Kome (Kevin) Shomglin, PhD , Rene Faber, PhD
The authors describe the development of an ultra scale-down anion exchange membrane adsorber, and demonstrate scalability to larger-scale devices.
Closures for Pharmaceutical Preparations: A Review of Design and Test Considerations
By Tim Sandle, PhD
The author examines the use of closures for products intended for injection.
A 25-Year Retrospective on Computer System Validation
By Sharon Strause
This month, Sharon Strause, an industry consultant, provides a look back at "Computer System Validation Part I: Testing and Verification of Applications Software" by Leonard J. Goren.
From the Editor
When Disaster Strikes at Home
By Angie Drakulich
Keeping tabs on crucial medicines should be part of consumers' and manufacturers' emergency-preparedness plans.
Global Reports
Discovery Pipeline: Understanding Cellular Reprogramming
By Amy Ritter, PhD
Recent research examines the sequence of events underlying cellular reprogramming, which may aid in better control of the production of induced pluripotent stem cells.
Report from South Korea
By Jane Wan
The South Korean market is characterized by its aging population and an affluent population. Growth potential is limited as it has evolved to a developed market and industry players expect it to have established regulations.
Regulatory Beat
Research Policies Pose New Challenge for US Administration
By Jill Wechsler
White House and Congress likely to struggle over funding for bio/pharmaceutical regulation.
Boot Camp Technical Guide
Glycan Analysis: A Primer
NIBRT's Pauline Rudd on what to expect when performing glycan analysis.
Bioanalytical Best Practices
Bioanalytical Methods for Sample Cleanup
By Roger N. Hayes
Preparation of biological samples for chromatographic analyses.
Final Word
Patents and Postapproval Batch Testing
By Kevin Murphy , Andrew Nason
Can postapproval FDA filings immunize pharma companies from patent lawsuits?

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