Report to Obama: Target fill/finish to speed vax-making

Scientists have recommended to President Obama that fill/finish, potency assays and sterility testing are three areas that can be improved to speed the production of pandemic vaccine. The President's Council of Advisors on Science and Technology has submitted a 65-page document, Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza, outlining what the government can do to speed up production.

The council advises that pandemic vaccine production time could be halved in three years. One recommendation: government incentives to drive development of the equipment used in fill/finish operations, "a major rate-limiting step" in production. Advisors suggest that a comprehensive six-month review of fill/finish technology is a first step. One focus of the review would be facilities, with an eye toward evaluating the capabilities of existing plants against the promise of new plants.

The advisors also suggest that effort be devoted to improving potency assays, work that should be driven by the FDA and contractors. The council projects that a four- to eight-week time savings may be available in this area.

Similarly, the council suggests that changes to sterility testing could test time in half.

- see this article
- here's the report

Suggested Articles

A biotech that worked with a nutritional products maker on the API for its clinical-stage radiation drug, is buying all of the manufacturing know-how.

Merck KGaA is selling a manufacturing site and its Allergopharma allergy drug business as it focuses on newer meds.

In a first, the FDA and Indian oversight agencies worked together to block illegal drugs from entering the U.S.