BioPharm International, June 2013 - BioPharm International

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BioPharm International, June 2013
Features
An Integrated Prefilled Syringe Platform Approach for Vaccine Development
By Kingman Ng , Ronald Malone , Changyun Xiong , Xuefeng Yi
An integrated focus on product design, development, operation, and control.
A Generic Growth Test Method for Improving Quality Control of Disposables in Industrial Cell Culture
By Brian Horvath , Valerie Liu Tsang , Weimin Lin , Xiao-Ping Dai, PhD , Kurt Kunas , Greg Frank
Quality control for disposable-bags
Using Plastic for Parenteral Containers
By Jennifer Markarian
A Q&A with SCHOTT Pharmaceutical Systems and West Pharmaceutical Services
Regulatory Beat
Congress Considers Legislation to Secure Drug Supply Chain
By Jill Wechsler
Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.
European Beat
A Lifecycle Approach to Process Validation
By Sean Milmo
A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.
Manufacturing Best Practices
Flexibility in Biopharmaceutical Manufacturing
By Simon Chalk
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.
Boot Camp Business Guide
Misconceptions of Maintenance and Reliability: A Biopharmaceutical Industry Survival Guide
By Gerald Clarke , James Bailargeon , Paul Boles , Rob Christman , Steve Jones
The authors provide common misconceptions and key concepts behind reliability engineering.
Inside Standards
The Meaning of Metrics
By Susan J. Schniepp
Companies can use metrics as a tool to help drive positive change and quality process improvements.
Outsourcing Insights
Drug Approval Trends Don't Extend to CMOs
By Jim Miller
Approvals of new drugs are on an upward swing, but only a few CMOs are benefiting.
Emerging Markets
Navigating Emerging Markets: Southeast Asia
By Jill E. Sackman, PhD
A unique demographic and payer mix make ASEAN an increasingly attractive region.
Global Report
Report from Taiwan
The Taiwanese government engages in regulatory science in a move to boost its pharmaceutical sector.
From the Editor
Trust in the Pill Bottle
By Rita Peters
Ranbaxy's $500 million settlement for producing adulterated drugs and fradulent data provides a cautionary tale for patients, FDA, and drug manufacturers.

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