Offshore Opportunity on the Rise
The supply base for preclinical and clinical development services continues to expand in China.
How to Avoid Becoming a Biotech Zombie, Part 3
Two business models that companies can follow to map their strategy from concept to implementation.
Biologics Regulation in India
India is restructuring its regulation of biopharmaceuticals to help the country's industry compete internationally.
FDA Encourages Quality by Design Initiatives
More informed submissions may lead to regulatory flexibility for postapproval changes.
What Lies Ahead for Biotech in 2008
Despite the rising fears about a slowing economy, the biotech industry will continue to maintain its momentum this year.
How to Ensure Smooth Technology Transfer
A comprehensive process and analytical transfer package can speed up your product's time to market and save costs.
Creating Affordable Vaccines for India
How an electronics engineer led the first Indian company to carry out indigenous development of a recombinant vaccine.
Evaluation of Dendritic Cell Products Generated for Human Therapy and Post-Treatment Immune Monitoring
Emerging therapies pose challenges for standardizing QC.
Can the FDA Live up to its Promise of a Risk-Based Approach to Compliance?
The expanding globalization of the industry poses a challenge for international enforcement.
What the Heparin Crisis Should Tell Us
The cause of the heparin crisis is still unknown. We do know, however, that the FDA is severely underfunded.
Cleaning Validation for Biopharmaceutical Manufacturing at Genentech, Inc. Part 2
Need a standard to follow? Just ask, What would Genentech do?
