Abstract: The present invention is related to novel polysaccharide-protein conjugate vaccine formulation comprising of at least one of Neisseria meningitidis serogroup A, C, Y, W or X synthetic oligosaccharides (Men A, C, Y, W, X), each said oligosaccharide (OS) being conjugated separately to carrier protein, either none or at least one but not exceeding four bacterial capsular polysaccharide (PS) of Men A, C, Y, W or X, each said polysaccharide being conjugated separately to carrier protein, one or more buffer along with pharmaceutically acceptable components/excipients, with or without an adjuvant. The formulation is a mono- or bi- or multi-valent, liquid or lyophilized or a Liquid-Lyo combination formulation providing desired osmolality, desired pH, high stability and desired immunogenicity.

Abstract: The present invention relates to an improved process of conjugation to obtain synthetic oligosaccharide-protein (OS-PR) conjugates. The process of synthetic OS-PR conjugation is a rapid process providing oligosaccharide-protein conjugates which are highly immunogenic and elicit specific and homogenous immune responses. The synthetic oligosaccharide comprising of four to eight repeating units of respective monomers and at least one in-built terminal amino linker, said synthetic polysaccharide mimics natural polysaccharide obtained from gram negative bacteria such as Neisseria meningitidis serogroups A, C, Y, W, X and Haemophilus influenzae and carrier protein is obtained from gram positive bacteria such as Clostridium tetani (tetanus toxoid) or Corynebacterium diphtheriae (CRM197) or their recombinant versions. The conjugation chemistry of the said oligosaccharide-protein conjugate of the present invention is thio-ether linkage. The present invention takes complete process time in the range of 14-22 hours.

Abstract: The present invention relates to an improved process of conjugation to obtain synthetic oligosaccharide-protein (OS-PR) conjugates. The process of synthetic OS-PR conjugation is a rapid process providing oligosaccharide-protein conjugates which are highly immunogenic and elicit specific and homogenous immune responses. The synthetic oligosaccharide comprising of four to eight repeating units of respective monomers and at least one in-built terminal amino linker, said synthetic polysaccharide mimics natural polysaccharide obtained from gram negative bacteria such as Neisseria meningitidis serogroups A, C, Y, W, X and Haemophilus influenzae and carrier protein is obtained from gram positive bacteria such as Clostridium tetani (tetanus toxoid) or Corynebacterium diphtheriae (CRM197) or their recombinant versions. The conjugation chemistry of the said oligosaccharide-protein conjugate of the present invention is thio-ether linkage. The present invention takes complete process time in the range of 14-22 hours.