Manufacturing
We manufacture BioThrax® (Anthrax Vaccine Adsorbed) at our facilities in Lansing, Michigan using well-established
vaccine manufacturing procedures. In Lansing, we own a multi-building campus on
approximately 12.5 acres, which includes facilities for bulk manufacturing of BioThrax® (Anthrax Vaccine Adsorbed),
including fermentation, filtration and formulation, as well as for raw material
storage and in-process and final product warehousing. In February 2006, we began
construction of a new 50,000 square foot manufacturing facility on our Lansing campus
as a large-scale commercial manufacturing plant. Subject to regulatory approval,
we expect that the new manufacturing facility will serve as our primary BioThrax® (Anthrax Vaccine Adsorbed)
manufacturing facility. We also recently commissioned a new pilot plant on our Lansing
campus that we are using for process development.
In addition to the Lansing campus, we own two buildings of approximately 145,000 square feet each on a 15-acre site in Frederick, Maryland. We are in the preliminary phase of establishing plans to build out this site, and those plans contemplate that the site would to provide laboratory space, product development and pilot plant
production capabilities, full-scale commercial manufacturing operations, warehouse
and storage facilities, fill and finish operations and administrative office space.
We believe that manufacturing our products and product candidates independently will provide us cost savings and greater control over the manufacturing and regulatory
approval and oversight process, accelerate product development timelines and allow
us to expand our base of manufacturing know-how that we can then apply to the development
and manufacture of future product candidates. However, we currently rely on contract
manufacturers and other third parties to manufacture the supplies of our immunobiotic
product candidates that we require for preclinical and clinical development, and
we use a third-party filling contractor to fill vials of our licensed product BioThrax® (Anthrax Vaccine Adsorbed)
. We expect that we may continue to use third parties for
production of preclinical, clinical, and commercial supplies of some of our product
candidates and possibly for filling operations.
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