Process for Manufacturing Vaccines at the CPV center

TETANUS

Tetanus is a severe acute infectious disease caused by a neurotoxin produced by Clostridium tetani bacteria which enters the body through open wounds or skin lesions and causes muscle spasms. Depending on the location and severity of the infection Tetanus can lead to death. Tetanus is not transmitted from one individual to another. Transmission occurs as the result of a cut, burn, necrotic tissue or skin injury that becomes dirty with dust, earth, manure, feces, etc. that are contaminated with spores of the bacteria.

The manufacturing process of tetanus anatoxin begins by using a bacterial strain of Clostridium tetani grown in specific liquid culture media under anaerobic conditions for bacterial growth. The fermentation process is carried out in bioreactors in the following steps: clarification, tangential ultrafiltration systems, clarifying and sterilizing filtration, detoxification process, purification (tangential ultrafiltration, chromatography and sterilizing filtration), as well as the preparation of solutions, CIP cleaning, SIP sterilization and decontamination/neutralization of effluents.

 

 DIPHTHERIA

Diphtheria is an infectious contagious acute disease caused by Corynebacterium diphtheriae which causes inflammation of the mucous lining of the throat, nose, trachea and bronchi, inflammation occurs in the mucous membranes of the upper airways or in small skin wounds. The pathogenicity of C.diphtheriae occurs via invasion of the tissue site by bacterial proliferation and colonization followed by toxin production that causes the death of eukaryotic cells and tissues by inhibiting protein synthesis in cells. Transmission happens by means of direct contact between a sick person and a susceptible person via droplets of secretion eliminated by coughing, sneezing or when speaking or by skin lesions.

The manufacturing process of diphtheria anatoxin begins by using a bacterial strain of Corynebacterium diphtheriae grown in specific liquid culture media under aerobic conditions for bacterial growth. The fermentation process is carried out in bioreactors in the following steps: clarification, tangential ultrafiltration systems, clarifying and sterilizing filtration, detoxification process, purification (tangential ultrafiltration, chromatography and sterilizing filtration), as well as the preparation of solutions, CIP cleaning, SIP sterilization and decontamination/neutralization of effluents.

 

 ACELLULAR PERTUSSIS

Whooping cough or pertussis is a contagious acute infectious disease which compromises and adheres to the cilia of the respiratory tract (trachea and bronchi) and is caused by Bordetella pertussis bacteria. This disease is characterized by three stages: catarrhal stage with symptoms similar to a cold followed by the paroxysmal stage with more acute and severe symptoms and a last convalescent stage of gradual recovery. Transmission happens by direct contact between a sick person and a susceptible person, through droplets of secretion eliminated by coughing, sneezing or when speaking.

The manufacturing process of acellular pertussis begins by using a bacterial strain of Bordetella pertussis grown in specific liquid culture media under aerobic conditions for bacterial growth. The fermentation process is carried out in bioreactors in the following steps: extraction, purification, detoxification/inactivation, adsorption, as well as the preparation of solutions, CIP cleaning, SIP sterilization and decontamination/neutralization of effluents.

 

 HEPATITIS B

Hepatitis B is transmitted via contact with bodily fluids and is still among the worst threats to public health leading to about 1 million deaths per year. In addition to the cases of death, hundreds of millions of people suffer from chronic infection many of whom develop cirrhosis and liver cancer. Prevention by means of mass immunization is the only effective strategy to prevent the disease.

The manufacturing process of Hepatitis B begins by using a recombinant strain of Pichia augusta grown in specific liquid culture media under aerobic conditions for the growth of yeast and to allow the expression of surface antigens of the virus. The fermentation process is carried out in bioreactors in the following steps: extraction, purification, as well as preparation of solutions, CIP cleaning, SIP sterilization and decontamination/neutralization of effluents.