Havana, Mar 15 (ACN)
The National Center for the Production of Laboratory Animals (Cenpalab) is essential for the development of the Cuban biotechnology industry and has been crucial for the preclinical of the island’s vaccine candidates against COVID-19 .
Miguel Ángel Esquivel Pérez, head of the Department of Technological Surveillance at the institution, told Cubadebate that they had colonies of monkeys, and no one asked them until the current pandemic arrived.
One of the problems that has occurred in the world with vaccines is that there have not been enough monkeys; It is not an animal that is achieved overnight, he stressed. Right now we can develop several vaccines in parallel because we had enough for preclinical studies, he said.
A vaccine has a scale, the zoological scale; first a mouse, then a curiel (…) to non-human primates, before moving on to man, he explained about the preclinical of immunogens, which precedes clinical tests. In addition, the area of toxicology is key in the release of batches of vaccines and drugs to the market, the so-called regulatory toxicology.
To release each product, there are internationally accepted protocols that must be followed, by which its toxicity is tested; they must meet a series of requirements and there are protocols regarding which animal is tested, in what dose. That has to be repeatable, that is, when I say that this product is approved, I have determined it with a methodology that you can repeat to verify if it is true, he said.
In addition, Cenpalab houses the only industrial rabbit breeding in Cuba, with more than three thousand white rabbit breeders. This animal is sensitive to pyrogens, substances that produce fever; any vaccine, anything that is injected into a human in the country must first be tested on a rabbit from this institution; If you don’t get a fever, you’re pyrogen-free, he explained.
In this reference center in Cuba, in addition to the production of laboratory animals for all the scientific institutions of the island, research is carried out, protein plants are grown, food is produced for animals and diets are designed (for their laboratory animals and for those in zoos).
Likewise, bioproducts, diagnostic kits and vaccines for veterinary use are developed; Toxicology services (experimental and regulatory) are offered and pre-clinical vaccines are carried out, to which is added the development and implementation of automatic solutions for precision agriculture. In total, 16 species of animals are kept there under conventional, farm conditions, and 22 of gnotobiotics (free of specific pathogens and used in specific research or as a gene bank).
Likewise, in Cuba, Cenpalab is the governing and coordinating entity of the National System of Laboratory Animals (Sinal). We are advocates that laboratory animals are used rationally, but currently, and not only on the island but internationally, there are many cases in which it is essential to use them, the only way, said Esquivel Pérez. There are tests, processes, dose definitions that we must necessarily do in animals today, said the head of the Technological Surveillance Department.
All biotechnology products have a complete quality management system, which defines what needs to be done at all times; the Center for State Control of Medicines, Equipment and Medical Devices registers the products and regulates everything they must comply with.
Here we have more than one weekly audit, from the CECMED (Center for State Control of Medicines, Medical Equipment and Devices) to international organizations, and the reviews do not remain with the scientists, they go to the man who feeds or handles the animals. He pointed out that most of the center’s workers are medium technicians, accredited in good practices in animal handling and must periodically pass training courses and be evaluated.
In 2013, Cecmed established to implement and verify compliance with the harmonized criteria of the Institutional Committees for the Care and Use of Laboratory Animals (Cicual), “in all Institutions that provide experimental results using laboratory animals, as part of the requests for regulatory procedures ”.
In said regulation, the institution pointed out that “the quality of the experimental results that are part of the pharmacodynamic, pharmacokinetic and toxicological characterization of drugs, vaccines and implantable medical devices, is seriously compromised when conducting tests on animals does not consider the protection of the animal welfare, stress control, pain and the humane end point ”.
Today Cenpalab has more than 200 clients in the country, both from BioCubaFarma (including the Center for Genetic Engineering and Biotechnology, the Center for Molecular Immunology, the Finlay Vaccine Institute and the Immunoassay Center), and the Ministries of Agriculture (one of the main ones is the Labiofam company) and Public Health.
Source: ACN
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