Patent ID: 9173931
Filing Date: 2015-11-03
Classification: A61K,A61P,Y02A

Abstract:
1. A method for preparing a meningococcal-tetanus toxoid conjugate vaccine in commercial volumes, the method comprising: reacting a meningococcal polysaccharide with an oxidizing agent, whereby a solution of an aldehyde-activated meningococcal polysaccharide is obtained; reacting a tetanus toxoid protein with hydrazine dichloride at an acidic pH, whereby a solution of a hydrazine-activated tetanus toxoid protein is obtained; purifying by diafiltration said solution of hydrazine-activated tetanus toxoid protein to process at least five liters of solution; reacting the aldehyde-activated meningococcal polysaccharide with the hydrazine- activated tetanus toxoid protein at a pH of from 5 to 7 in the presence of sodium cyanoborohydride, whereby a meningococcal-tetanus toxoid conjugate is obtained; neutralizing unreacted aldehyde groups with adipic acid dihydrazide; purifying by diafiltration the resulting solution to process a volume of at least two liters, producing a purified meningococcal-tetanus toxoid conjugate vaccine, and concentrating the purified meningococcal-tetanus toxoid conjugate vaccine by tangential flow ultrafiltration, yielding a concentrated purified meningococcal-tetanus toxoid conjugate vaccine, whereby the meningococcal-tetanus toxoid conjugate vaccine capable of stimulating an immune response is obtained in commercial volumes.