Individual polysaccharide quantification in polyvalent pneumococcal conjugate vaccine using rate nephelometry. 2023

Burki Rajendar, and Jaya Sheela Pydigummala, and Ganti Sreenivasa Rao, and Ramakrishna Chigurambotla, and Ramesh V Matur
Research & Development, Biological E Limited, Shameerpet, Hyderabad 500078, India. Electronic address: Rajendar.Burki@biologicale.com.

The multivalent pneumococcal conjugate vaccine (PCV) contains purified polysaccharides of different serotypes conjugated to a carrier protein. Testing the final formulated product for individual serotype polysaccharide content is critical in vaccine quality control which requires an assay specific to each serotype polysaccharide present in the formulated product. Antibodies specific to the serotypes specific polysaccharide were used in rate nephelometry assay for quantifying individual serotype polysaccharides in the formulated vaccine. Generally, native polysaccharide (NP) have been used as reference standard. However, the polysaccharide antigen in the vaccine product is in the conjugate form (CRM197 linked) and hence using NP as a reference standard may not be suitable. Activated quenched polysaccharide (AQP) as a reference standard in rate nephelometry would be more appropriate. The epitope structure of AQP closely represents the polysaccharide-protein conjugate drug product (DP) after trypsin digestion. Hence, AQP was evaluated as a novel reference standard for the accurate and precise determination of individual polysaccharides in the multivalent DP. Rate nephelometry assay using AQP could be used for DP release and stability for monitoring time-dependent changes in the product and establishing the shelf life. A similar strategy could be applied to test and release monovalent or multivalent polysaccharide-protein conjugate vaccines (Meningococcal, Haemophilus influenza Type B, Typhoidal, and non-typhoidal salmonella).

UI MeSH Term Description Entries
D009391 Nephelometry and Turbidimetry Chemical analysis based on the phenomenon whereby light, passing through a medium with dispersed particles of a different refractive index from that of the medium, is attenuated in intensity by scattering. In turbidimetry, the intensity of light transmitted through the medium, the unscattered light, is measured. In nephelometry, the intensity of the scattered light is measured, usually, but not necessarily, at right angles to the incident light beam. Turbidimetry,Nephelometry,Turbidimetry and Nephelometry
D011134 Polysaccharides Long chain polymeric CARBOHYDRATES composed of MONOSACCHARIDES linked by glycosidic bonds. Glycan,Glycans,Polysaccharide
D000906 Antibodies Immunoglobulin molecules having a specific amino acid sequence by virtue of which they interact only with the ANTIGEN (or a very similar shape) that induced their synthesis in cells of the lymphoid series (especially PLASMA CELLS).
D018074 Vaccines, Conjugate Semisynthetic vaccines consisting of polysaccharide antigens from microorganisms attached to protein carrier molecules. The carrier protein is recognized by macrophages and T-cells thus enhancing immunity. Conjugate vaccines induce antibody formation in people not responsive to polysaccharide alone, induce higher levels of antibody, and show a booster response on repeated injection. Conjugate Vaccine,Conjugate Vaccines,Vaccine, Conjugate
D022242 Pneumococcal Vaccines Vaccines or candidate vaccines used to prevent infections with STREPTOCOCCUS PNEUMONIAE. Pneumococcal Polysaccharide Vaccine,Pneumococcal Vaccine,Pneumovax,Pnu-Imune Vaccine,Pnu Imune Vaccine,PnuImune Vaccine,Polysaccharide Vaccine, Pneumococcal,Vaccine, Pneumococcal,Vaccine, Pneumococcal Polysaccharide,Vaccines, Pneumococcal

Related Publications

Burki Rajendar, and Jaya Sheela Pydigummala, and Ganti Sreenivasa Rao, and Ramakrishna Chigurambotla, and Ramesh V Matur
June 2002, Biologicals : journal of the International Association of Biological Standardization,
Burki Rajendar, and Jaya Sheela Pydigummala, and Ganti Sreenivasa Rao, and Ramakrishna Chigurambotla, and Ramesh V Matur
November 1991, The New England journal of medicine,
Burki Rajendar, and Jaya Sheela Pydigummala, and Ganti Sreenivasa Rao, and Ramakrishna Chigurambotla, and Ramesh V Matur
December 1980, JAMA,
Burki Rajendar, and Jaya Sheela Pydigummala, and Ganti Sreenivasa Rao, and Ramakrishna Chigurambotla, and Ramesh V Matur
February 2012, JAMA,
Burki Rajendar, and Jaya Sheela Pydigummala, and Ganti Sreenivasa Rao, and Ramakrishna Chigurambotla, and Ramesh V Matur
March 2015, The New England journal of medicine,
Burki Rajendar, and Jaya Sheela Pydigummala, and Ganti Sreenivasa Rao, and Ramakrishna Chigurambotla, and Ramesh V Matur
January 1978, Bulletin of the World Health Organization,
Burki Rajendar, and Jaya Sheela Pydigummala, and Ganti Sreenivasa Rao, and Ramakrishna Chigurambotla, and Ramesh V Matur
February 1983, Recenti progressi in medicina,
Burki Rajendar, and Jaya Sheela Pydigummala, and Ganti Sreenivasa Rao, and Ramakrishna Chigurambotla, and Ramesh V Matur
January 1987, Antibiotics and chemotherapy,
Burki Rajendar, and Jaya Sheela Pydigummala, and Ganti Sreenivasa Rao, and Ramakrishna Chigurambotla, and Ramesh V Matur
January 2020, PloS one,
Burki Rajendar, and Jaya Sheela Pydigummala, and Ganti Sreenivasa Rao, and Ramakrishna Chigurambotla, and Ramesh V Matur
June 2005, Clinical and experimental immunology,
Copied contents to your clipboard!