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Novel Method for Separating PT, FHA and PRN from Bordetella Pertussis

IP.com Disclosure Number: IPCOM000214753D
Publication Date: 2012-Feb-06
Document File: 17 page(s) / 2M

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Abstract

A novel downstream process method is developed to separate Pertussis Toxin (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN). The method uses simplified steps to obtain antigens with purity more than 95%. The antigens purified using this method can be used in acellular pertussis stand-alone or combination vaccine.

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Novel Method for Separating PT, FHA and PRN from Bordetella Pertussis

Abstract

A novel downstream process method is developed to separate Pertussis Toxin (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN). The method uses simplified steps to obtain antigens with purity more than 95%. The antigens purified using this method can be used in acellular pertussis stand-alone or combination vaccine.

Novel Method for Separating PT, FHA and PRN from Bordetella Pertussis

The present method relates to separating PT, FHA and PRN from Bordetella Pertussis for pertussis vaccine. It particularly relates to a novel, simplified downstream process to separate and purification of PT, FHA and PRN.

PT, FHA and PRN obtained by this method have a purity level more than 95%, and the process used in this invention has simple steps, which greatly reduces process time and avoids antigen degradation. The antigens purified can be used in acellular pertussis stand-alone or combination vaccine.

Background

Whooping cough (Pertussis) is highly contagious respiratory infection, which commonly affects infants and young children, but is increasingly reported in older children, adolescents and adults. Pertussis is caused by the bacteria Bordetella pertussis. Bordetella pertussis is gram-negative coccobacillus, Size: (0.5~1.5)um x


(0.2-0.5)um, Encapsulated, no spore, non-motile, have bacterium hair (only phase


I)


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Vaccine is the main method to prevent pertussis. Pertussis vaccine is part of WHO Expanded Program on Immunization (EPI) since 1974, which China joined in 1982. Pertussis vaccine often served together with diphtheria and tetanus toxoids to form DTP combination vaccine.

Pertussis vaccine can be grouped into whole-cell pertussis (wP) vaccines and acellular pertussis (aP) vaccines. wP vaccines are based on killed B. pertussis strains, provides high protection efficiency (around 78%), but frequently associated with minor adverse reactions. The reactogenicity of wP vaccine was thought to be too high to permit routine use in older children, adolescents and adults. In another hand, aP vaccines contain ≥1 of the separately purified antigens from pertussis, including PT, FHA, PRN, and FIM type 2 and type 3. It has less adverse reactions than wP, and have gradually become the dominant type in the industrialized world. Besides that, aP containing vaccines with reduced concentrations of the antigen have been formulated for use in adolescents and adults, pregnancy, health-care workers.

According to a market report, there are 460 million dose shortages per year in China. China Expand Program of China National Immunization (EPI) stats a tendency to replace whole cell DTP with acellular DTP in EPI. But due to DTaP insufficient supply, replacement should start from injection 4 and finally to injection 1.

Until now, Pertussis toxin (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), Agglutinogens (AGGs) or Fimbriae (FIMs) are used in acellular pe...