abstract |
The present invention provides methods for preparing stable multivalent protein-polysaccharide conjugate pneumococcal vaccine formulations. unstable momentary formulations show optimal adsorption percentage for each conjugate in which aggregation can be prevented by employing: i) individual or separate adsorption for conjugates that otherwise show lower adsorption percentage by combined adsorption, ii) histidine-acid buffer system succinic coupled with pH shift from neutral to acid ph, iii) a protein to polysaccharide ratio of 0.5 to about 1.4, iv) a six-blade rushton turbine impeller in the formulation containers. |