[Quality control and documentation of effectiveness of bacterial autovaccines with the use of flow cytometry]

Autovaccines are bacterial preparations derived from non pathogenic autologous bacteria of human origin. In the course of microbiological therapy these individual bacterial vaccines are mainly used in conditions of chronic inflammatory disorders of the respiratory or gastrointestinal tract as well as allergic diseases. Being autologous bacterial preparations from the patients own flora the control of batch variabilities of these individual products represents a special challenge for the manufacturer. A flow cytometric method suitable for batch control of autovaccines is described. The method is based upon the determination of the de novo expression of the CD69 antigen on different leucocyte subpopulations in whole blood cultures after preincubation of cells with different batches of autovaccines. Thus, manufacturers of autovaccines and other microbial preparations are able to reliably control batch variability and immunological activity of such products in accordance with drug regulations. The results of this study highlight the pharmaceutical quality of the individual therapeutic agent autovaccine.