Patent ID: 8999697
Filing Date: 2015-04-07
Classification: A61K,A61P,C07H,C08B,C12P

Abstract:
1. A process for producing a solution containing substantially purified capsular polysaccharides from a Streptococcus pneumoniae cell lysate, the process comprising the steps of: (a) providing a fermentation broth comprising bacterial cells that produce a selected (b) lysing the bacterial cells in step (a) with a lytic agent, thereby producing a cell lysate comprising cell debris, soluble proteins, nucleic acids, and polysaccharides; (c) clarifying the cell lysate of step (b) using centrifugation or filtration to remove cell debris, thereby producing a clarified cell lysate; (d) ultrafiltering and diafiltering the clarified cell lysate of step (c) to remove low molecular weight impurities and increase polysaccharide concentration, thereby producing a retentate; (e) lowering the pH of the retentate of step (d) to less than 4.5 to precipitate protein and nucleic acids, thereby forming an acidified retentate solution; (f) holding the acidified retentate solution formed in step (e) for a time sufficient to allow settling of the precipitate, followed by filtration or centrifugation of the acidified retentate solution, thereby producing a clarified polysaccharide solution; (g) filtering the clarified polysaccharide solution of step (f) through an activated carbon filter; (h) ultrafiltering and diafiltering the filtered solution produced by step (g), thereby producing a concentrated purified polysaccharide solution; and (i) filtering the concentrated purified polysaccharide solution produced by step (h) using a sterile filter; whereby a solution containing substantially purified capsular polysaccharides is produced.