Medicago USA, a wholly owned subsidiary of Medicago Inc., has completed the construction of its commercial-scale facility in Research Triangle Park (RTP), North Carolina. This virus-like-particle plant-based vaccine facility includes a fully automated greenhouse, customized infiltration systems, and a state-of-the-art extraction and purification unit. The 97,000-square-foot facility is targeted to produce 10 million doses of pandemic influenza vaccine per month.
On an annual basis, the facility is expected to have production capacity of 30 million doses of quadrivalent seasonal influenza vaccine or 120 million doses of pandemic influenza vaccine.
- In August 2010, Medicago signed a US$21 million Technology Investment Agreement with the Defense Advanced Research Projects Agency (DARPA) to rapidly develop a scaled-up process capable of producing substantial doses of immunogenic, pandemic vaccine in a brief amount of time.
- To support this objective, Medicago constructed a 97,000-square-foot vaccine facility in Research Triangle Park (RTP), North Carolina. This state-of-the-art facility is cost-effective and scaled up for Medicago's VLP plant-based vaccine technology, ultimately for the delivery of current good manufacturing practice (cGMP)-grade vaccine.
- This DARPA project was part of the Blue Angel influenza vaccine rapid response demonstration program which sought to identify new ways to produce large amounts of high-quality vaccine-grade protein in less than 3 months in response to emerging and novel biologic threats.
Production of more than 10 million doses of H1N1 VLP influenza vaccine in one month
- In July 2012, Medicago announced the successful completion of a key milestone under the agreement with DARPA at our facility in Durham, North Carolina.
- The milestone was the production of at least 10 million doses of H1N1 VLP influenza vaccine candidate in one month (the “rapid fire test").
- As part of the rapid fire test, production of the H1N1 VLP influenza vaccine began on March 25th, 2012, and was completed in 30 days on April 24th, 2012.
- The production lots were then tested by a third-party laboratory to confirm both the immunogenicity of the vaccine candidate and the number of doses produced.
- Testing confirmed that a single dose of the H1N1 VLP influenza vaccine induced protective levels of neutralizing antibodies in an animal model.
- The production of significantly more than 10 million doses, as defined by the testing conditions, was confirmed.
Medicago earned the full US$21 million in DARPA milestone awards demonstrating the scalable manufacturing of its plant-expressed VLP vaccines. The validation process of the North Carolina facility is ongoing.