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WHO Proposes Reference Standard For Adventitious Virus Detection

Executive Summary

Emerging global standard could speed testing of biologics and gene therapies for stray viral particles, while sparing laboratory animals.

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US FDA Expects Updates On Investigational Gene Therapy CMC Improvements

Final gene therapy IND CMC guidance clarifies expectations on process evolution, distinguishing drug substances from products, cGMP oversight and more.

FDA's CMC Guidance For Investigational Gene Therapies Reflects Broader CMC Evolution

New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference.

Biotechs Urged to Prevent Viral Risks That Cost Genzyme Nearly $300 Million

Biotechs should bite the bullet and invest in media treatment to avoid viral contamination, experts say. They point to last year's temporary shutdown of Genzyme's Allston Landing, Mass., which has cost the company $293 million in added expenses and lost revenues so far, and may have reduced the market for its top product by as much as 20 percent. Genzyme looks to add treatment now, but many others still take their chances. What happened when a mouse virus snuck into Genentech's plant 15 years ago? Genentech added high temperature short time heat sterilization treatment and never caught another virus. How Biomarin expanded on Genentech's approach with added layers of protection, including the use of disposable technology. Tips on how to add heat treatment of media for a commercial product.

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