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Novavax, Xcellerex double-team H1N1
Novavax is stepping up the pace of its H1N1 vaccine manufacturing process as it works through a two-stage, 4,000-subject trial in Mexico. The novel vaccine maker is working with Xcellerex, using the latter's single-use FlexFactory biomanufacturing platform, development expertise, and manufacturing services to ramp up to commercial scale and begin production.
Novavax has just launched a trial of the vaccine in Mexico to support registration there. In the deal, Xcellerex will provide the development expertise and vaccine manufacturing in exchange for manufacturing supply fees.
The vaccine is based on Novavax's virus-like particle (VLP) technology. VLPs mimic viruses in structure but lack their infectious genetic material. Over the next quarter, Xcellerex will step up manufacturing volumes until reaching full commercial scale, says CEO Joseph Zakrzewski. "This deal further validates what we've been saying about how quickly this technology can be used. It continues to prove out the technology."
Zakrzewski also says that Xcellerex is "getting ready" to submit an undisclosed vaccine of its own.
Earlier this month, specialty biopharma Itero also capitalized on Xcellerex's combination of disposable technology, contract manufacturing and drug development capabilities to help shorten development time for an undisclosed therapeutic protein drug candidate. Xcellerex is using its PDMax process development platform and the FlexFactory disposable technology in providing the services.
Comments
By Anonymous | Posted 12:26pm | October 28, 2009
and why is it registered in Mexico and in trials in Mexico??
By Chris Dippel | Posted 1:14pm | October 28, 2009
My guess is that Novavax, being a small company with a novel production technology, decided to get its technology used by partnering with mid-sized regional vaccine companies (that is, non-US/EU) (see the company website for details of their partnership in India). The recent shortages of seasonal and pandemic flu vaccine in the US demonstrate that the major vaccine companies have not made the investment into capacity to supply the "major" markets so Novavax is aiming to supply a world need that the big companies have ignored. If you're concerned that the Mexican trials and registration process is less rigorous than that of the US, it's just as good if not better (less politics). If you are interested in global health issues, see my blog, Retronyma, at http://cdippel.wordpress.com/.
By Anonymous | Posted 1:59pm | December 7, 2009
To clarify: The five large vaccine manufacturers have not ignored the idea of increasing capacity, but had not chaosen to do so for economical reasons. Any one or more of the five could have expanded and "scooped" the market through volume expansion. Influenza vaccine manufacturing was a risky business......up until a pandemic strain was identified. Now they are reaping the benefits of being in the business where others have dropped out.
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