Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Multivalent pneumococcal polysaccharide-protein conjugate composition

a polysaccharide and conjugate technology, applied in the field of medicine, can solve the problems of infants and young children not responding well to most pneumococcal polysaccharides

Inactive Publication Date: 2009-09-17
WYETH LLC
View PDF2 Cites 6 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a multivalent immunogenic composition that includes a capsular polysaccharide from each of 13 distinct serotypes of Streptococcus pneumoniae conjugated to a carrier protein. The composition can also include an adjuvant, such as aluminum-based adjuvant, and a physiologically acceptable vehicle. The capsular polysaccharides can be prepared from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. The immunogenic composition can be administered in a single 0.5 mL dose formulated to contain specific amounts of each saccharide, carrier protein, adjuvant, and buffer. The technical effect of the invention is to provide a more effective and comprehensive immunogenic composition for the prevention of pneumococcal disease.

Problems solved by technology

However, infants and young children respond poorly to most pneumococcal polysaccharides.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Multivalent pneumococcal polysaccharide-protein conjugate composition
  • Multivalent pneumococcal polysaccharide-protein conjugate composition
  • Multivalent pneumococcal polysaccharide-protein conjugate composition

Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of S. Pneumoniae Capsular Polysaccharide Serotype 1

Preparation of Master and Working Cell Banks

[0069]S. pneumoniae serotype 1 was obtained from the American Type Culture Collection, ATCC, strain 6301. Several generations of seed stocks were created in order to expand the strain and remove components of animal origin (generations F1, F2, and F3). Two additional generations of seed stocks were produced. The first additional generation was made from an F3 vial, and the subsequent generation was made from a vial of the first additional generation. Seed vials were stored frozen (<−70° C.) with synthetic glycerol as a cryopreservative. In addition to frozen vials, lyophilized vials were prepared for the F4 generation. For cell bank preparation, all cultures were grown in a soy-based medium. Prior to freezing, cells were concentrated by centrifugation, spent medium was removed, and cell pellets were re-suspended in fresh medium containing a cryopreservative, such as synthetic g...

example 2

Preparation of Serotype 1 Pneumococcal Saccharide

CRM197 Conjugate

Activation and Conjugation

[0086]Containers of purified polysaccharide were thawed and combined in a reaction vessel. To the vessel, 0.2 M sodium carbonate, pH 9.0 was added for partial deacetylation (hydrolysis) for 3 hours at 50° C. The reaction was cooled to 20° C. and neutralization was performed by 0.2 M acetic acid. Oxidation in the presence of sodium periodate was performed by incubation at 2-8° C., and the mixture was stirred for 15-21 hours.

[0087]The activation reaction mixture was concentrated and diafiltered 10× with 0.9% NaCl using a 30K MWCO membrane. The retentate was 0.2 μm filtered. The activated saccharide was filled into 100 mL glass lyophilization bottles and shell-frozen at −75° C. and lyophilized.

[0088]“Shell-freezing” is a method for preparing samples for lyophilization (freeze-drying). Flasks are automatically rotated by motor driven rollers in a refrigerated bath containing alcohol or any other a...

example 3

Preparation of S. Pneumoniae Capsular Polysaccharide Serotype 3

Preparation of Master and Working Cell Banks

[0096]S. pneumoniae serotype 3 was obtained from Dr. Robert Austrian, University of Pennsylvania, Philadelphia, Pa. For preparation of the cell bank system, see Example 1.

Fermentation and Harvesting

[0097]Cultures from the working cell bank were used to inoculate seed bottles containing soy-based medium. The bottles were incubated at 36° C.±2° C. without agitation until growth requirements were met. A seed bottle was used to inoculate a seed fermentor containing soy-based medium. A pH of about 7.0 was maintained with sterile sodium carbonate solution. After the target optical density was reached, the seed fermentor was used to inoculate an intermediate seed fermentor. After the target optical density was reached, the intermediate seed fermentor was used to inoculate the production fermentor. The pH was maintained with sterile sodium carbonate solution. The fermentation was termi...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
pHaaaaaaaaaa
optical densityaaaaaaaaaa
temperatureaaaaaaaaaa
Login to View More

Abstract

An immunogenic composition having 13 distinct polysaccharide-protein conjugates and optionally, an aluminum-based adjuvant, is described. Each conjugate contains a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) conjugated to a carrier protein. The immunogenic composition, formulated as a vaccine, increases coverage against pneumococcal disease in infants and young children globally, and provides coverage for serotypes 6A and 19A that is not dependent on the limitations of serogroup cross-protection.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. application Ser. No. 11 / 644,207, filed Dec. 22, 2006, which is a continuation-in-part of U.S. application Ser. No. 11 / 395,593, filed Mar. 31, 2006, which claims the benefit of U.S. Provisional Application No. 60 / 669,605, filed Apr. 8, 2005, each of which is hereby incorporated in its entirety by reference herein.FIELD OF THE INVENTION[0002]The present invention relates generally to the field of medicine, and specifically to microbiology, immunology, vaccines and the prevention of infection by a bacterial pathogen by immunization.BACKGROUND OF THE INVENTION[0003]Streptococcus pneumoniae is a leading cause of meningitis, pneumonia, and severe invasive disease in infants and young children throughout the world. The multivalent pneumococcal polysaccharide vaccines have been licensed for many years and have proved valuable in preventing pneumococcal disease in elderly adults and high-risk patients. Ho...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(United States)
IPC IPC(8): C07K14/315C07H1/00
CPCA61K39/092A61K2039/6031A61K39/385A61K2039/6037A61P11/00A61P31/04A61P37/04A61K39/02A61K39/09A61K39/39A61K47/42A61K47/50
Inventor HAUSDORFF, WILLIAM P.SIBER, GEORGE RAINERPARADISO, PETER R.PRASAD, A. KRISHNA
Owner WYETH LLC
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com