BIOLOGICAL DEFENSE VACCINE PRODUCTION FACILITY

File: 120396_sep96_decls73_0002.txt
Page: 0002
Total Pages: 10

Subject: BIOLOGICAL DEFENSE VACCINE PRODUCTION FACILITY                  

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003203

Folder Title: BIOLOGICAL DEFENSE VACCINE PRODUCTION FACILITY                                                  

Document Number:          1

Folder SEQ  #:         66





            demonstrably effective immunization program emphasizes the U.S.
            goal of defense and deterrence. The immunization program also
            demonstrates the high priority our nation places on individual
            soldier survivability.
                A need was clearly established for an adequate reliable
            source of vaccines to protect service members from the effects of
            biological warfare agents. The Army, as the DOD Executive Agent
            for biological defense, determined that the construction of a
            goverrmept-owned vaccine production facility (VPF) was the
            preferred way to meet DOD's long-term biological defense needs.
            It was also determined that such a facility must be multi-
            functional and state-of-the-art, incorporate numerous stand-alone
            production areas, meet Food and Drug Administration requirements,
            and be capable of diverse vaccine production technologies as
            recombinant DNA procedures, toxin purification, fermentation
            production of spore forming bacteria, viral genetics and
            inicroencapsulation.

            SHORTCOMINGS OF EXISTING SYSTEMS,

                A comprehensive market survey determined there is essentially
            no commercial interest in producing biological defense vaccines
            and DOD has no assurance that current producers will be willing
            to continue production. Currently, there are only a very limited
            number of biological defense vaccine producers. They posses
            limited surge capability, possess almost no flexibility (ability
            to change production to another vaccine), and the U.S. must
            accept significant dependence on foreign supply.

            SYSTEM DESCRIPTION.

                The VPF provides DOD a vaccine production and stockpile
            capability. It has the flexibility and surge capability to meet
posed is a facility with six
            production suites and ancillary facilities. Capabilities of the
            production suites are: two for spore-forming organisms
            (fermentation units required for organisms such as anthrax), and
            one each for non-fermentation microbial growth, cell culture ,
            egg work, and non-spore forming fermentation. (Specific vaccines
            have different production requirements. Generally, they include:
            bacterial growth (fermentation and agar), viral vaccines in
            bottles.and flasks, embryonated eggs, organic solvents for
            synthetic peptides, and microencapstilatioii.1 Each'production-
            suite will contain walk-in cold rooms, walk-in incubators, and
            r@ired laboratories. Ancillary facilities include: product
            finishing areas (formulation, bottling, filling, etc.), solution
            preparation areas, glassware washing areas, warehouse space,
            administrative and personnel support area, long-term storage
            areas, utility rooms, animal space, and quality control areas. A
            design study is now underway to better characterize the VPF.
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Document 10 f:/Week-36/BX003203/BIOLOGICAL DEFENSE VACCINE PRODUCTION FACILITY/biological defense vaccine production facility:11259610130813
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = BIOLOGICAL DEFENSE VACCINE PRODUCTION FACILITY
Folder Seq # = 66
Subject = BIOLOGICAL DEFENSE VACCINE PRODUCTION FACILITY
Document Seq # = 1
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 25-NOV-1996