The ACA Operating Rules

ACAThe main operating rules of ACA are:

  • development of a standard sample for the determination of anticomplementary activity;
  • standardization of the method for determining an anticomplementary activity;
  • study of the influence of hemolytic system components and the initial pH value of immunoglobulin drugs on the result of the determination of anti-complementary activity;
  • the study of the effect of guinea pig complement on the result of the determination of anticomplementary activity;
  • evaluation of the possibility of using gelatin-saline inalternatively gelatin barbital buffer solution;
  • validation of optimized anticomplementary activity determination method;
  • determination of the requirements for the standard sample to identify an anticomplementary activity;
  • the choice of the candidate in the standard sample for the determination of anticomplementary activity;
  • study of the possibility of using human immunoglobulin drugs for intravenous administration as a candidate for a standard sample for the determination of an anticomplementary activity;
  • exploring the possibility of using human immunoglobulins for intramuscular administration as a candidate for a standard sample to determine an anticomplementary activity;
  • study of the possibility of using human immunoglobulins subjected to heating as a candidate for positive control of a standard sample for the determination of an anticomplementary activity;
  • obtaining a standard sample for the determination of an anticomplementary activity.

Category: General Issues

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