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Size Characterization of Mycobacterium bovis BCG (Bacillus Calmette Guérin) Vaccine, Tice™ Substrain

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Abstract

Reconstituted, lyophilized, attenuated Mycobacterium bovis, Bacillus Calmette Guérin (BCG) vaccine, Tice™ substrain, was characterized using a Coulter Multisizer and a HIAC/Royco counter. The primary organism has an equivalent spherical diameter approximating 1 µm but the BCG cell suspension is heavily aggregated. The cumulative size distribution of the suspension fits a log-probit plot and this information can be used to determine the total number of particles per ampoule. The instrumental count may be related to the viable count. The state of dispersion was unaffected by mild shear (syringe aspiration or ultrasound) and only slightly affected by the addition of cetylpyridinium chloride or sodium tauroglycolate.

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Authors and Affiliations

  1. Institute for Tuberculosis Research, Department of Pharmaceutics, College of Pharmacy, University of Illinois at Chicago, 833 South Wood Street, Chicago, Illinois, 60612

    Amy Zhang & Michael J. Groves

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  1. Amy Zhang
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  2. Michael J. Groves
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Zhang, A., Groves, M.J. Size Characterization of Mycobacterium bovis BCG (Bacillus Calmette Guérin) Vaccine, Tice™ Substrain. Pharm Res 5, 607–610 (1988). https://doi.org/10.1023/A:1015954316139

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