Big Changes Ahead for Biotech Manufacturers
To expand coverage amidst the economic crisis, Obama will be looking hard for ways to cut healthcare costs.
Disposable Technologies Implementation: Understanding and Managing Risks
In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to manage supply chain risk.
The Case for Outsourcing Biologics Process Development
Four reasons why outsourcing may be the best option, and key factors to consider when selecting a provider.
How to Avert Supply-Chain Quality Failures
To stave off quality issues associated with production processes, a centralized and enterprise-wide quality management initiative must be enforced.
Regulation of Biomarker Clinical Laboratory Tests Used in Personalized Medicine
A clear oversight framework for biomarker clinical laboratory tests used in personalized medicine is required.
How to Make the Business Case for Quality by Design
No time for QbD? How to convince management to make it a priority.
Indian Biopharmaceutical Industry: 2008 in Review
A closer look at the past year's development in India.
Will The Biotech Industry Survive The Financial Crisis?
The meltdown in the financial markets represents a sea change in the world of financing that will continue to affect the flow of much needed capital into the sector for the foreseeable future.
The New Era of Process Validation
The FDA's revised process validation guidance manages to explain the underlying concepts of Quality by Design without every using the phrase.
Quality by Design: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes—Part 1
Using multivariate experiments to define acceptable ranges.
Antibody Purification Using Membrane Adsorbers
Results from a process developed for a commercial antibody.
