BioPharm International, May 2009 - BioPharm International

ADVERTISEMENT

ADVERTISEMENT

BioPharm International, May 2009
Cover
Monitoring of Biopharmaceutical Processes: Present and Future Approaches
By Paul Konold , Rob Woolfenden II , Cenk Undey , Anurag S. Rathore, PhD
This article reviews some of the commonly used approaches for process monitoring as well as the evolution of process monitoring in the Quality by Design (QbD) paradigm.
Features
Application of Overall Equipment Effectiveness to Biopharmaceutical Manufacturing
By Beth H. Junker
How to optimize facility utilization and improve plant performance.
QbD: Convincing the Skeptics
By Ronald Branning , Lynn Torbeck
Without a rigorous discussion of the pros and cons of QbD, its tremendous benefits will be lost.
Establishing a Successful CRO–Client Relationship
By Emma Waite
It is essential to build and maintain a good working relationship between the client and contract research organization.
Royalty Interest Investing: Addressing the Out-License Assignability Issue
By Timothy R.M. Bryant , Jeffrey A. Jung
Several legal considerations are key to protect the buyer and seller in royalty interest transactions.
Columns and Departments
The Least of Four Evils
By Laura Bush
Avoiding healthcare reform is not the best option for the pharmaceutical industry.
Comparative Effectiveness Research to Shape Biotech Studies
By Jill Wechsler
Authorities are pushing for CE; manufacturers prefer to focus on value.
Declining Market Demand Intensifies Competition
By Jim Miller
The current competitive environment is forcing service providers to evaluate their business models and focus on value and performance.
When Less is More: Lean Can Help Reduce Costs and Improve Compliance Simultaneously
By Chris S. Driscoll
Use Lean techniques to improve manufacturing compliance
Efficient Compliance Without Re-inventing the Wheel
By Victor Bornsztejn , Brian Collins
Why the industry needs to review its traditional approach to facility validation

ADVERTISEMENT

ADVERTISEMENT

Click here