Certain bacteria induce disease by secreting toxins, such as tetanus and diphtheria. Inactivated toxins prepared by physical and chemical methods are the main active ingredients of toxoid vaccines. Toxoid vaccines retain the immunogenicity that activates the production of specific antibodies but do not cause disease symptoms.
Currently approved human toxoid vaccines include diphtheria and tetanus vaccines, and veterinary vaccines include multivalent Pasteurella toxoid and porcine pleuropneumonia Actinobacillus toxoid.
Yaohai Bio-Pharma has over a decade of microbial CDMO experience. Based on the Biosafety Level 1 (BSL-1) and Biosafety Level 2 (BSL-2) GMP workshop, we provide a one-stop solution for microbial strain development, fermentation, toxoid extraction and purification, and aseptic filling.
According to the customized needs of customers, we provide clients with toxoid drug substance (DS, API) or vaccine drug product (DP) that meet quality standards, as well as GMP production records and test reports.
Some Approved Toxoid Vaccines Are listed as Follows:
|
Application
|
Toxoid Name
|
Strain Type
|
Platform
|
|
Human
|
Diphtheria Toxoid (DT)
|
Corynebacterium Diphtheriae
|
Microbial fermentation systems
Centrifugation and homogenization equipments
High/low pressure chromatography systems
Conjugate reaction tank
Biosafety Level: BSL-2
GMP Quality System
|
|
Tetanus Toxoid (TT)
|
Clostridium Tetani
|
|
Veterinary
|
Multivalent Pasteurella Toxoid
|
Multivalent Pasteurella
|
|
Hemolysin Toxins ApxI, ApxII, Apxlll
|
Actinobacillus Pleuropneumoniae
|
|
Human and Veterinary
|
Other microbial-derived toxins (BSL-1, BSL-2)
|
Toxoid Vaccine Drug Product Process
Deliverable
|
Grade
|
Deliverables
|
Specification
|
Applications
|
|
GMP
|
Drug substance
|
Bacteria derived toxin
|
Investigational new drug (IND),
Clinical trial authorisation (CTA),
Clinical trial supply,
Biologic license application (BLA),
Commercial supply
|
|
Drug product
|
Vials (liquid)
|
|
Vials (lyophilized)
|
|
Other dosage forms
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