BioPharm International, March 2008 - BioPharm International

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

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