Daptacel components

Daptacel is a sterile isotonic suspension of pertussis antigens and diphtheria and tetanus toxoids adsorbed on aluminum phosphate. Daptacel components are:

Each 0.5 mL dose contains:

  • diphtheria toxoid
  • tetanus toxoid
  • acellular pertussis antigens
    detoxified pertussis toxin (PT)
    filamentous hemagglutinin (FHA)
    pertactin (PRN)
    fimbriae types 2 and 3 (FIM)
  • Aluminum phosphate
  • Residual formaldehyde
  • Residual glutaraldehyde
  • 2-phenoxyethanol (not as a preservative)

Daptacel has less components compared to Pentacel or Pediarix.

The acellular pertussis vaccine components are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium.

The FIM components are extracted and co-purified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography.

PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate.

Corynebacterium diphtheriae is grown in modified Mueller’s growth medium. After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion.

Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate.

The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection.

Source:
https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert—DAPTACEL.pdf

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