The ACA Operating Rules

The 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.