QUALITY-CONTROL AND DOCUMENTATION OF EFFI CACY OF BACTERIAL AUTOVACCINES BY FLOW-CYTOMETRY

Autovaccines are bacterial preparations derived from non pathogenic au tologous bacteria of human origin. In the course of microbiological th erapy these individual bacterial vaccines are mainly used in condition s of chronic inflammatory disorders of the respiratory or gastrointest inal tract as well as allergic diseases. Being autologous bacterial pr eparations from the patients own flora the control of batch variabilit ies of these individual products represents a special challenge for th e 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 wi th different batches of autovaccines. Thus, manufacturers of autovacci nes and other microbial preparations are able to reliably control batc h variability and immunological activity of such products in accordanc e with drug regulations. The results of this study highlight the pharm aceutical quality of the individual therapeutic agent autovaccine.