The first ever monoclonal antibody obtained starting from transgenic plants with the purpose of purifying a human vaccine was registered in Cuba by the State Center for the Control of Medication Quality (CECMED), the regulating authority in charge of the control of medical drugs of the Ministry of Public Health.
This is the first ever monoclonal antibody registered in the world for this purpose and coming from genetically modified plants, according to Dr. Carlos Borroto, the deputy director of Havana�s Genetic Engineering and Biotechnology Center (CIGB).
Monoclonal antibodies are laboratory substances that are joined to specific cells, and each one only recognizes a protein or antigen as its target, explains a report on Granma daily newspaper.
The antibody is used in the process of purifying the active pharmaceutical ingredient of the Hepatitis B vaccine produced in Cuba by the CIGB sold under the trade mark of Heberbiovac-HB.
In comparison with the traditional production process, starting from the ascitic liquid of the mouse, obtaining the antibody from genetically modified tobacco plants, has advantages due to higher levels of safety and industrial possibilities, said Doctor Borroto.
Borroto made it clear that the tobacco plantations that were genetically modified have nothing to do with the commercial strains of that plant that are cultivated in Cuba.
He noted that the CIGB has taken appropriate actions to avoid possible risks to the environment when cultivating transgenic strains. This production process is confined to special controlled growing areas, where the technology specifically created with that purpose is in use, according to the Good Agricultural Production Practices demanded in the obtaining of vegetable biomass for pharmaceutical applications, Dr. Borroto confirmed.
This monoclonal antibody obtained from transgenic plants obtained the license granted by the National Center of Biological Safety that is part of the Cuban Ministry of Science, Technology and the Environment.
Approval by CECMED guarantees that the monoclonal antibody obtained as well as the innovative process that precedes it, has quality standards that are equivalent to the one obtained from the mouse ascitic liquid according to the existing international standards for the pharmaceutical industry.