Rybalkin M. Scientific and experimental substantiation of the composition and technology of “Candidocyde” vaccine solution for injection for prevention and treatment of candidiasis

The thesis is devoted to scientific and experimental substantiation of the composition and technology of the vaccine solution for injection (VSI) for prevention and treatment of candidiasis (PTC). The general methodological concept for pharmaceutical development of VSI for PTC has been proposed. The general monograph “Terminology used in monographs on immunobiolo¬gical drugs” (5.2.1.) of section 5.2 “General texts on biological medicinal products” planned to be included into the SPhU 2.0, Appendix 3, has been developed. The VSI for PTC has been created for practical medicine and pharmacy. The manufacturing specification for “Candidocyde” VSI for PTC has been substantiated and experimentally developed. The manufacturing formula and technological flowchart has been worked out. The pack type, shelf life and storage conditions of the VSI developed based on C. albicans and C. tropicalis fungi have been experimentally determined. The methods for identification and quantitative determination of substances in VSI have been developed; the basic indicators of quality of the vaccine have been studied; the project of the Quality Control Methods (QCM) has been elaborated. The data of immunological and biological studies of “Candidocyde” VSI proposed have been generalized