Application of toxin neutralization on albino mice for potency control test of serum containing specific anti-tetanus antibody

Abstract

Background/Purpose: Intravenous Globulin (IV. Globulin), one of biological products, is used to
provide passive immune protection by increasing the concentration of specific antibodies and
neutralizing pathogenic microorganisms or virulent factors of pathogenic microorganisms. This study
aimed to evaluate the suitability of the toxin neutralization technique in white mice for quality control
of immunoglobulins containing antitoxin against tetanus bacteria.
Methods: descriptive laboratory study. We explored precision (repeatability and intermediate
precision) of the toxin neutralization technique in white mice for quality control of immunoglobulins
containing antitoxin against tetanus bacteria at National Institute for Control of Vaccines and
Biologicals, Vietnam.
Results: Potency of IV. Globulin was 21.40IU/ml with CV of 2.56% and 21.67 IU/ml with CV of
2.38% when we performed experiments for intermediate precision and repeatability, respectively. The
results demonstrate that the toxic neutralization technique in white mice meets the requirements for
accuracy and precision to control the quality of immunoglobulins containing antibody against tetanus
toxin.
Conclusion: We successfully applied toxin neutralization technique using white mice model to
determine the potency for quality control of tetanus antitoxin serum with high precision CV <5%.