GUINEA PIG POTENCY TESTING FOR ANTHRAX VACCINE

File: 102596_sep96_decls5_0002.txt
Page: 0002
Total Pages: 3

Subject: GUINEA PIG POTENCY TESTING FOR ANTHRAX VACCINE                  

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003202

Folder Title: GUINEA PIG POTENCY TESTING FOR ANTHRAX VACCINE                                                  

Document Number:          1

Folder SEQ  #:         13


     01.@14 @91 1 5 : 0 7'a3Ol 663 2982 HQ US                         zoom oo.3








                                                            SGRD-PLA
                                                           7 January 1991

                               INFORMATION PAPER

        SL'BIECT: Guinea pig Potency Tesdn- ior And= vaccine
                                    t,

           Backgmund- Each lot of anffi= vaccine that is produced must be tested for potency
        in a -@ea pi,- challenge rno&l as described in the Code of Federal Regulations (21 CFR
        620.23).

        2. At least three groups of @ea pigs (no less Ow eight per group) must be immunized
        with serial @-fold dilutions of the test lot of vaccine and a reference lot of vaccine.
        LTnimmu@ guinea pi-S serve as the contmi-s@
                         0

        3- Fourteen days aftr the @ea pigs are with 0.5 ml of vaccine, they are
        challenged by injection with a spore suspension (1000 spores) of the @lent Vonum
        s@ of Bacillus an@cis. Guinea pigs @ observed for 10 days and deaths are recorded-

        4. The test is valid provided that the following L@teria @ met:

           @ 'n- protective response of the vaccine is graded with respect to the dludons of
        vaccine given.

           b. All control animals die within 10 days.

           c. The avera@e time to deilth of the vaccine immunized guinea pigs is no less than [he
                    w
        averace time to death in the reference vaccine group.

           d- 'Ibt number of survivors in the vaccine immunized group is no less than the
        number in the reference soup.

        5. Tber-- have been historical problems vath this potency tes@ due mainly to the variability
        of the guinea pi,-S- Statistical information has recently been collected to show that
        variab ty between tests is no @ater than the variability within a tesl

ne,
        but rather one of an inconsistent response in the guinea pigs. A repeat test must be
        peiform@ requiring @ additional 24 days before release of that vaccine IoL

        7@ The Nfichigan Department of Public Health (NTM is the only licensed manufacturer
        for antbzax vaccine. They are Acted to a small area for the guinea pig potency testing
        (approx=ately 100 guinea pi-s can be hou@ at one time). In anticipation of large
        amounts of bulk vaccine being shipped to MPH for potency testing, bottling, and labeling,
        the capability for guinea pig potency testing must be assured.

        S. Tn order for another facility to coi)duct the potency test, they must be FDA approved
        Che in compliance %ith Good Laborawry Practices), must have BI,3 containment, must

Document 3 f:/Week-36/BX003202/GUINEA PIG POTENCY TESTING FOR ANTHRAX VACCINE/guinea pig potency testing for anthrax vaccine:1018961354306
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003202
Unit = OTSG
Parent Organization = HSC
Folder Title = GUINEA PIG POTENCY TESTING FOR ANTHRAX VACCINE
Folder Seq # = 13
Subject = GUINEA PIG POTENCY TESTING FOR ANTHRAX VACCINE
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 = 18-OCT-1996