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Multivalent pneumococcal polysaccharide-protein conjugate composition

一种肺炎链球菌、组合物的技术，应用在医学领域，能够解决侵袭性肺炎球菌疾病增加等问题

Inactive Publication Date: 2015-08-12
SK CHEM 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

[0047] Example 1: Preparation of Streptococcus pneumoniae capsular polysaccharide

[0048] Cultivation of S. pneumoniae and purification of capsular polysaccharides are performed as known to those skilled in the art. S. pneumoniae serotypes were obtained from the American Type Culture Collection (ATCC). Streptococcus pneumoniae is characterized by capsular and immobile, Gram-positive lancet-shaped diplococci and alpha hemolysis in blood agar medium. Serotypes are identified by a capsular swelling test using specific antisera (US Patent No. 5,847,112).

[0049] Preparation of cell bank

[0050] Several generations of seed stock were generated to expand the strain and remove components of animal origin (F1, F2 and F3 generations). Two additional generations of seed stock were produced. The first additional generation was made from F3 vials, and subsequent generations were made from vials of the first additional generation. Seed vials were stored frozen (≤-70°C) using synth...

Embodiment 2

[0061] Example 2: Preparation of Streptococcus pneumoniae capsular polysaccharide-CRM 197 conjugate

[0062] Activates different serotypes of polysaccharides according to different pathways and then binds them to the CRM 197 . Activation treatments include size reduction of capsular polysaccharides to target molecular weights, chemical activation, and buffer exchange by ultrafiltration. The purified CRM 197 Binds to activated capsular polysaccharide and the conjugate is purified using ultrafiltration and finally filtered through a 0.22 μm filter. Process parameters such as pH, temperature, concentration and time are as follows.

[0063] (1) Activation

[0064] step 1

[0065] The polysaccharide of each serotype was 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. The solution w...

Embodiment 3

[0089] Example 3: Formulation of a multivalent pneumococcal conjugate vaccine

[0090] Based on the batch volume and bulk sugar concentration, calculate the volume required for the final bulk concentrate. After the desired amount of 0.85% sodium chloride (physiological saline), polysorbate 80 and succinic acid buffer were added to pre-labeled formulation containers and bulk concentrate was added. The article was then mixed well and sterile filtered through a 0.22 μm membrane. During and after addition of the bulk aluminum phosphate, gently mix the formulated bulk. 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 each serotype polysaccharide, 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; and about 100 μg polysorbate 80.

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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 2 or 9N. 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: by combining serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F derived from 12 Streptococcus pneumoniae serotypes and Streptococcus pneumoniae serotype 2 or 9N capsular polysaccharide bound 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 the 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 published by the National Bureau of Statistics, pneumonia was 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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/48A61K47/36A61K39/39A61P37/00
CPCA61K47/48261A61K2039/55505A61K2039/6037A61K47/4833A61K39/092A61K9/0019A61K47/02A61K47/12A61K47/26A61K39/116A61K47/6415A61K47/646A61P11/00A61P31/00A61P31/04A61P37/00A61P37/04A61K47/50A61K39/39A61K47/36A61K39/09A61K2039/545A61K2039/6031A61K2039/70
Inventor 朴万勋金勋梁智慧梁先荣卢明柱朴秀真申珍焕
Owner SK CHEM CO LTD
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