Current trends in development and manufacturing of higher-valent pneumococcal polysaccharide conjugate vaccine and its challenges.

Autor: Jain SS; Savitribai Phule Pune University, Department of Biotechnology, Pune, Maharashtra, 411007, India; Serum Institute of India Pvt. Ltd., Hadapsar, Pune, Maharashtra, 411028, India. Electronic address: shital.jain@seruminstitute.com., Singh VK; Serum Institute of India Pvt. Ltd., Hadapsar, Pune, Maharashtra, 411028, India. Electronic address: vikas.singh@seruminstitute.com., Kante RK; Serum Institute of India Pvt. Ltd., Hadapsar, Pune, Maharashtra, 411028, India. Electronic address: rajesh.kante@seruminstitute.com., Jana SK; Serum Institute of India Pvt. Ltd., Hadapsar, Pune, Maharashtra, 411028, India. Electronic address: skjana@seruminstitute.com., Patil RH; Savitribai Phule Pune University, Department of Biotechnology, Pune, Maharashtra, 411007, India. Electronic address: rpatil@unipune.ac.in.
Jazyk: angličtina
Zdroj: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2024 Aug; Vol. 87, pp. 101784. Date of Electronic Publication: 2024 Jul 24.
DOI: 10.1016/j.biologicals.2024.101784
Abstrakt: Pneumococcal conjugate vaccines (PCVs) have been developed to protect against pneumococcal diseases caused by the more than 100 serotypes of the bacterium Streptococcus pneumoniae. PCVs primarily prevent pneumococcal infections such as sepsis, bacteraemia, meningitis, otitis media, pneumonia, septicaemia, and sinusitis among infants, adults, elderly, and immunocompromised individuals. The current available PCVs only cover a limited number of serotypes, and there is an immense need for developing higher-valent PCVs that can protect against non-vaccine serotypes to overcome challenges like serotype replacement and antibiotic resistance. The main challenges for developing higher valent PCVs are the complexity of the manufacturing process comprising polysaccharide fermentation, purification, modification or sizing of multiple polysaccharides and conjugation between polysaccharides and carrier proteins, the stability of the conjugates, and the immunogenicity of the vaccine. Different manufacturing processes have been explored to produce higher valent PCVs using different serotypes of S. pneumoniae and conjugation with different carrier proteins. The global coverage of higher valent PCVs are still low, mainly due to the high cost and limited supply of the vaccine. This review focuses on the existing and emerging manufacturing processes and challenges associated with higher-valent pneumococcal PCV development.
Competing Interests: Declaration of competing interest The authors declare no conflict of interest.
(Copyright © 2024 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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