When Less is More: Lean Can Help Reduce Costs and Improve Compliance Simultaneously
Use Lean techniques to improve manufacturing compliance
QbD: Convincing the Skeptics
Without a rigorous discussion of the pros and cons of QbD, its tremendous benefits will be lost.
Application of Overall Equipment Effectiveness to Biopharmaceutical Manufacturing
How to optimize facility utilization and improve plant performance.
Royalty Interest Investing: Addressing the Out-License Assignability Issue
Several legal considerations are key to protect the buyer and seller in royalty interest transactions.
The Least of Four Evils
Avoiding healthcare reform is not the best option for the pharmaceutical industry.
Efficient Compliance Without Re-inventing the Wheel
Why the industry needs to review its traditional approach to facility validation
Establishing a Successful CRO–Client Relationship
It is essential to build and maintain a good working relationship between the client and contract research organization.
Declining Market Demand Intensifies Competition
The current competitive environment is forcing service providers to evaluate their business models and focus on value and performance.
Monitoring of Biopharmaceutical Processes: Present and Future Approaches
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.
Comparative Effectiveness Research to Shape Biotech Studies
Authorities are pushing for CE; manufacturers prefer to focus on value.
