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Multivalent pneumococcal polysaccharide-protein conjugate composition

A technology of Streptococcus pneumoniae and a composition, which is applied in the medical field and can solve the problems of increasing invasive pneumococcal disease and the like

Inactive Publication Date: 2015-08-12
SK BIOSCI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, serotype coverage was limited to some regions and invasive pneumococcal disease was increased by serotypes not covered by Prevnar (notably 19A)

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment 1: Preparation of Streptococcus pneumoniae capsular polysaccharide

[0047] Cultivation of S. pneumoniae and purification of capsular polysaccharides were performed according to those known to those skilled in the art. S. pneumoniae serotypes were obtained from the American Type Culture Collection (ATCC). S. pneumoniae was characterized by capsules, immobility, Gram-positive lancetate diplococci and alpha hemolysis in blood agar medium. Serotypes were identified by the capsular swelling test using specific antisera (US Patent No. 5,847,112).

[0048] Cell bank preparation

[0049] Several generations of seed stock were generated to expand the strain and remove animal derived components (F1, F2 and F3 generations). Two additional generations of seed stocks were produced. A first additional generation was made from the F3 vial and subsequent generations were made from the first additional generation vial. Store seed vials frozen (≤-70°C), using synthetic ...

Embodiment 2

[0060] Embodiment 2: Preparation of Streptococcus pneumoniae capsular polysaccharide-CRM 197 conjugate

[0061] Activate polysaccharides of different serotypes according to different pathways, and then bind them to CRM 197 . Activation treatments include size reduction of capsular polysaccharides to target molecular weight, chemical activation, and buffer exchange by ultrafiltration. Purified CRM 197 Conjugate to activated capsular polysaccharide and purify the conjugate using ultrafiltration and finally filter through a 0.22 μm filter. Process parameters such as pH, temperature, concentration and time are as follows.

[0062] (1) activation

[0063] step 1

[0064] Polysaccharides of each serotype were diluted with water for injection, sodium acetate, and sodium phosphate to a final concentration range of 1.0 to 2.0 mg / mL. For serotype 1, sodium hydroxide (final base concentration 0.05M) was added and the solution was incubated at 50°C ± 2°C. Then, the solution was co...

Embodiment 3

[0088] Example 3: Preparation of multivalent pneumococcal conjugate vaccine

[0089] Based on the batch volume and bulk sugar concentration, calculate the volume needed for the final bulk concentrate. After the required amount of 0.85% sodium chloride (saline), add polysorbate 80 and succinate buffer to pre-labeled formulation containers, add bulk concentrate. The preparation was then mixed well and sterile filtered through a 0.22 μm membrane. Mix the formulated bulk gently during and after adding the bulk aluminum phosphate. Check and adjust pH if necessary. Store the formulated bulk product at 2-8°C. A 0.5 ml volume of product contains 2 μg of polysaccharides of each serotype, but 4 μg in the case of 6B; approximately 32 μg of CRM 197 Carrier protein; 0.125 mg elemental aluminum (0.5 mg aluminum phosphate) adjuvant; about 4.25 mg sodium chloride; about 295 μg sodium succinate buffer;

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PUM

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Abstract

Disclosed is an immunogenic composition having 13 different polysaccharide-protein conjugates. Each conjugate contains a capsular polysaccharide which is prepared from different serotypes of streptococcus pneumonia conjugated to a carrier protein, in particular 12 serotypes selected from the group consisting of serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, and serotypes 22F or 33F. The immunogenic composition formulated as a vaccine having an aluminum-based adjuvant increases coverage against pneumococcal disease in infants and young children.

Description

technical field [0001] The present invention relates to a multivalent immunogenic composition, comprising: derived from 12 Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and The capsular polysaccharides of Streptococcus pneumoniae serotypes 22F or 33F bind to carrier proteins such as CRM 197 ) prepared 13 different polysaccharide-protein conjugates. The present invention relates generally to the field of medicine, and in particular to microbiology, immunology, and prevention of pneumococcal disease in infants, children, and adults by immunization. Background technique [0002] Streptococcus pneumoniae is the leading cause of pneumonia. According to the 2010 death trend released by the National Bureau of Statistics, pneumonia is one of the top 10 causes of death, with 14.9 deaths per 100,000 people, an increase of 82.9% over 2000. The World Health Organization (WHO) also estimated that in 2012, 476,000 HIV-negative children aged 5 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/48A61K47/36A61K39/39A61P37/00
CPCA61K47/48261A61K2039/55505A61K2039/6037A61K47/4833A61K39/092A61K9/0019A61K47/10A61K47/6415A61K47/646A61K47/02A61K47/12A61P31/04A61P37/00A61P37/04A61K47/50A61K39/39A61K47/36
Inventor 朴万勋金勋梁智慧梁先荣卢明柱朴秀真申珍焕
Owner SK BIOSCI CO LTD
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