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
