Status: used as an intermediate; not marketed

Organizations involved:

Statens Seruminstitut – Manuf.; R&D; Tech.

Cross ref: See the entry for DTaP vaccine ( Certiva; #434) from North American Vaccine, Inc., now Baxter, which was manufactured using this intermediate product.

Description: Diphtheria Toxoid Concentrate (For Further Manufacturing Use) is a formulation of diphtheria toxoid, i.e., inactivated Corynebacterium diphtheriae bacterial toxin, detoxified or inactivated with formaldehyde. The diphtheria toxin is derived from C. diphtheriae cultured in Stainer’s Diphtheria Culture Medium, containing casein hydrolysate (bovine origin), further purified by precipitation with ammonium sulfate, and detoxified by incubation with formaldehyde.

Nomenclature: Diphtheria Toxoid/Statens [BIO]; Diphtheria Toxoid Concentrate (For Further Manufacturing Use) [FDA]

Companies.: The toxoid concentrate was developed and is manufactured by Statens Seruminstitut, CBER/FDA est. no. 1255 [for further manufacturing by North American Vaccine, Inc., now Baxter Hyland Immuno)].

FDA class: Biologic BLA

CBER class: Toxoids And Toxins For Immunization

Approvals: Date = 19980729; first approval; BLA, covers this product and Tetanus Toxoid Concentrate (For Further Manufacturing Use) from Statens Seruminstitut

Indications: [extracted from approval letter]:

for further manufacture to Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed under a shared manufacturing arrangement with North American Vaccine, Inc.

Status: This product was used and approved exclusively for further manufacture of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) or Certiva by North American Vaccine, Inc. (now Baxter Hyland Immuno). The approval for this product remains valid (4/2005), but Certiva’s approval has been withdrawn and is no longer manufactured.