Pharmaceutical development

Pharmaceutical Development Department 

A full cycle of development of the pharmaceutical process for the production of polysaccharide conjugate vaccines – a Haemophilus influenzae vaccine, a 16-valent conjugated polysaccharide vaccine and a 5-valent meningococcal vaccine. 


 Areas of work

·         Development and optimization of the production technology for polysaccharide conjugate vaccines 

·         Selection of strains producing target polysaccharides of pneumococci, meningococci and Haemophilus influenzae

·         Selection, adaptation and optimization of methods for quality control of intermediate products at each process stage

·         Selection of carrier proteins and development of the method of conjugation of the produced polysaccharides

·         Characterization of all intermediate products, development of specifications 

·         Validation and verification of methods with subsequent transfer to the quality control department 

·         Selection and justification of the design of this range of vaccines

·         Production of samples of experimental and pilot batches for preclinical and clinical trials

·         Process support during the scaling and launch of the technology