The grant is part of nearly $593m in contracts to establish three Centers for Innovation in Advanced Development and Manufacturing (CIADM) and a network of facilities to provide packaging support for medical countermeasure distribution. Novartis and Emerging Manufacturing Operations in Baltimore were the other two to win awards of $86m and $221m, respectively.
According to a recently released GAO report on the CIADMs, the three participants are required under their contracts with BARDA (Biomedical Advanced Research and Development Authority) to establish surge capacity to quickly manufacture influenza vaccine in a pandemic and secure a pandemic influenza vaccine candidate currently under development.
Cook Pharmica, JHP Pharmaceuticals, DSM Pharmaceuticals and Nanotherapeutics were also awarded $39.8m in contracts to establish a Fill Finish Manufacturing Network that will allow for the fill and finish of 117 million additional doses of pandemic influenza vaccine in 12 weeks.
A&M Facility
Gerald Parker – Texas A&M's current principal investigator, who took the helm last year after serving as deputy assistant secretary of Defense -- told us, “Texas A&M pioneered a first-in-class manufacturing facility to increase the flexibility for the simultaneous and sequential production of medical countermeasures (MCMs) directed against chemical, biological, nuclear and radiologic threats.”
The center is home to a number of different biomanufacturing advancements that have helped it forge ahead in the field of MCMs.
“For example, housed within the facility are mobile clean rooms (MCRs) - standalone, modular biopharmaceutical manufacturing spaces - that allow the center to support a wide range of adaptable platforms at a dramatically reduced cost compared to the current state of the art. The MCRs support the use of a variety of nimble, single-use manufacturing platforms in the production of MCMs, positioning the center to accelerate research and development of products germane to national security and public health,” Parker said.
The speed at which the center can manufacture vaccines also seems to be one of the keys in how it won the award from HHS.
The CIADM can produce up to 50 million doses of pandemic influenza vaccine within four months of receipt of the influenza strain, with the first doses being available within 12 weeks, Parker noted.
“To achieve this surge capacity, the center is focused on utilizing cell-based manufacturing platforms rather than traditional egg-based technologies for influenza vaccine production. The center will also develop and manufacture vaccines and treatments for chemical, biological, nuclear, and radiologic threats, and will be a national response platform for new and emerging infectious diseases like MERS and West Nile Virus,” he added.
As a public-private partnership, the center also leverages the expertise of Texas A&M University, small biotech firms and the development and manufacturing capabilities of large pharma companies, according to Parker.