Havana, 12 August 2022. The National Center for Biopreparations (BioCen) celebrates on August 14 the 30th anniversary of its creation transformed into a remarkable scientific-industrial complex, dedicated to the research, development and manufacture of biotechnological products, biopharmaceuticals, supplements, culture media, diagnostics and immunomodulators.
The institution, which has been certified as a High Technology Enterprise, currently has a highly qualified staff, made up of seven doctors of science, 70 master's degree holders, 49 top-level advanced technologists and 167 innovative technicians of the same category, among others.
Located in the municipality of Bejucal, province of Mayabeque, BioCen belongs to the BioCubaFarma Business Group, and today it is in charge of the production of more than 30 lines of Cuban biotechnology. Additionally, it carries out physical, chemical and biological quality tests and providing services under contract for the manufacture of active pharmaceutical ingredients.
Faced with the appearance and subsequent spread of COVID-19, BioCen redoubled its daily work and guaranteed the manufacture and timely delivery to the National Health System of the main national drugs that make up the Cuban treatment protocol for the pandemic.
It also produced the millions of doses of the Soberana 02 vaccine required to initiate Phase III clinical studies and then contribute to the Cuban vaccination program against the contagious disease.
Special mention should be made of the development, in a few months, of the first virus transport medium (BTV) obtained in Cuba, for the collection and safe transfer of nasopharyngeal and oropharyngeal clinical samples for the diagnosis of SARS-COV-2, in the national network of molecular biology laboratories.
SCIENTIFIC NEWS
Doctor of Science Alexis Labrada Rosado, director of Research and Development and founder of BioCen, told Granma newspapers that among the recent contributions is a new version of the transport medium for molecular diagnosis, whose registration should be obtained this year.
Called TAN (transport of nucleic acids), the product is capable of inactivating the SARS-COV-2 and Zika viruses, and prolongs the conservation time of the genetic material of the virus, does not require a cold chain and reduces the risk of infection of the medical personnel in charge of handling the samples.
When asked about the high priority research lines on which the institution is working, Dr. Labrada Rosado mentioned those related to Biomodulin-T, aimed at confirming, with clinical evidence, the effectiveness of the drug in the prevention of acute respiratory diseases in older adults suffering from COVID-19, which are part of a project nearing completion, undertaken in collaboration with the Institute of Hematology and Immunology.
"Another study on the use of Biomodulin-t itself in thymus hypoplasia in pediatric patients is in its final phase, while another study on its use in the recovery of depressed immunity levels in oncology patients undergoing radio and chemotherapy is underway.
According to the scientist, an immediate goal is to introduce technological improvements that will lead to a second generation of this drug with a greater diversity of applications.
The center is also undertaking a project aimed at developing new variants of the allergenic vaccines against three different dust mites, developed by BioCen several years ago (known as Valergen), in order to achieve greater effectiveness and long-term immunological memory, applying fewer doses, he pointed out.
We even intend to administer them sublingually in the form of drops, thus reducing the risk of adverse reactions, he added.
The portfolio of innovative projects being carried out includes those related to the formulation of faster means of diagnosis, based on nanostructural clays, in collaboration with the Center for Advanced Studies of Cuba, and for the prevention of environmental aspects, nutrition and lifestyles associated with Alzheimer's disease, stand out.
BioCen has an analytical platform for specialized assays for the release of drugs and national products, with high quality standards and committed to regulatory compliance.
The implementation and diversification of analytical tests made possible the creation of new value chains with the participation of different manufacturers and ensured the technical support for the evaluation of quality control and the release of leading products demanded by the National Health System.
This secured the correct performance of the stages of development, sanitary registration, manufacturing licenses and technological transfers of highly demanded drugs to confront COVID-19, such as Heberon, Hebertrans, Jusvinza, Biomodulin-T, among others, various plasma derivatives and sodium chloride serum. It also made sure the evaluation of vaccine candidates with the required security.
As the Director of Research and Development of BioCen explained, the analytical platform was advantageous, as it made up for the companies' financing deficit in the purchase of reagents, materials, equipment, as well as the execution of new investments and the contracting abroad of tests for quality control.
NATIONAL TECHNOLOGICAL INNOVATION AWARDS
- Development and application of the first therapeutic vaccines for the treatment of asthma in Cuba (2012).
- Design, development, introduction and generalization of diagnosticians for the detection of pathogenic microorganisms in blood (2017).
- Use of Biomodulin-T, from a preventive scenario, for the confrontation of COVID-19 in Cuba (2020).
- Design, development and generalization in Cuba of the first virus transport medium (BTV) for the confirmatory diagnosis by RT-PCR of COVID-19 (2020).
Source: Granma