Purified capsular polysaccharides of Streptococcus pneumoniae
Inventors
Burki, Rajendar • Kandimalla, Vivek Babu • Sriraman, Rajan • Matur, Ramesh Venkat • Mantena, Narender Dev • Datla, Mahima • SANGAREDDY, VEERAPANDU
Assignees
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Abstract
The invention relates to capsular polysaccharides of Streptococcus pneumoniae. More specifically, the present invention relates to sized and purified capsular polysaccharides of Streptococcus pneumoniae serotypes 2, 15A, 15C & 35B and process for their preparation.
Core Innovation
The disclosure relates to purified and sized Streptococcus pneumoniae capsular polysaccharides from serotypes 2, 15A, 15C and 35B, with an average molecular weight in the range of about 50–1000 kDa, including preferred subranges. The polysaccharides are produced and purified through filtration, ultrafiltration/diafiltration, detergent/CTAB treatment, and activated carbon/SiO2 polishing, followed by further ultrafiltration and NaCl diafiltration.
The disclosure further provides conjugates in which the sized polysaccharides are conjugated to carrier proteins, including PsaA and CRM197. Conjugation is described using CDAP activation, with monitoring and characterization including SEC-HPLC and SEC-MALLS, and the resulting conjugate average molecular weights are reported.
Vaccine formulations are described using multivalent compositions, including 17-valent and 24-valent examples, in which the conjugates are adsorbed to an aluminum phosphate gel. Immunogenicity is shown in rabbit immunization studies, with serotype-specific IgG responses measured by ELISA, and the 24-valent formulation is described as immunogenic with serotype-specific IgG responses.
Claims Coverage
Not explicitly described in patent.
Not explicitly described in patent.
Stated Advantages
The 24-valent formulation is immunogenic, producing serotype-specific IgG responses.
Documented Applications
Multivalent pneumococcal conjugate vaccine formulations, including 17-valent and 24-valent formulations, using aluminum phosphate gel as adjuvant.
Rabbit immunization use to assess immunogenicity, with serotype-specific IgG responses measured by ELISA.
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