AMED Research Program on Emerging and Re-emerging Infectious Disesses.
Study of antitoxins/antivenoms and their replacement by humanized monoclonal antibodies.[Ato Group]

Serum therapy

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Serum therapy

Currently, the only facility in Japan capable of producing antitoxin and antiserum is KMB (formerly the Research Institute for Chemotherapy and Serotherapy, Kumamoto).
In the case of equine serum, equine immunoglobulin is purified from the serum or plasma obtained by immunizing equines and collecting their blood, which is then filled into vials and formulated.

Production process of
bovine antitoxin preparation (example)

  1. 1

    Bovine immunization process

    • Immunization (basic, additional)
    • Blood collection
    • Serum and plasma separation
    Bovine immunization process
  2. 2

    Antivenom purification process

    • Pepsin digestion
    • Salting out, dialysis
    • Stock solution preparation
    Antivenom purification process
  3. 3

    Manufacturing process

    • Final bulk preparation
    • Filling
    • Lyophilization, sealing
    Manufacturing process