Sized Pneumococcal Capsular Polysaccharides for Conjugate Vaccines
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Solution Overview
Problem
There is a need for the development of additional multivalent pneumococcal conjugate vaccines with polysaccharides that are purified and sized in a simple and efficient manner, as existing vaccines do not effectively elicit an immune response in infants and the elderly.
Innovation Solution
Purified and sized capsular polysaccharides of Streptococcus pneumoniae serotypes 2, 15A, 15C, and 35B are prepared by cultivating the bacteria, lysing cells, purifying, and sizing the polysaccharides to an average molecular weight between 50 and 1000 kDa, followed by conjugation with carrier proteins like CRM197 or PsaA to enhance immunogenicity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If unconjugated pneumococcal polysaccharide vaccines are used, then the vaccine can be manufactured with simpler processes, but the immune response is poor in infants and young children
Solution Approach 1:
The patent combines polysaccharide antigens with carrier proteins to create conjugate vaccines. This composite structure allows the polysaccharide to be presented in a form that elicits T-cell dependent immune responses, overcoming the limitations of unconjugated polysaccharide vaccines while maintaining manufacturing feasibility
Solution Approach 2:
The patent modifies the molecular weight parameters of the polysaccharide components during purification and sizing processes. By controlling the polysaccharide size distribution, the vaccine achieves optimal immunogenicity for different age groups while maintaining a streamlined manufacturing process
2Reliability
If polysaccharides are purified and sized to specific molecular weights, then the immunogenicity is enhanced, but the manufacturing process becomes more complex
Solution Approach 1:
The patent divides the polysaccharide purification process into distinct stages: initial crude extraction, intermediate purification steps, and final sizing fractionation. This segmented approach allows each step to be optimized independently, achieving high immunogenicity through controlled molecular weight distribution while keeping the overall process manageable
Solution Approach 2:
The patent employs controlled parameter changes during purification, specifically adjusting pH, temperature, and ionic strength to selectively precipitate or solubilize polysaccharide fractions of different molecular weights. This enables precise sizing control without requiring excessively complex equipment or multiple processing steps
Data Source
AI summary
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.