2024-01-08 22:15:36
Scientists devised and patented a synthetic molecule for the detection of HIV and hepatitis A, C and E.
Its development is the result of collaborative work between the Product and Process Development area of the Blood Derivatives Laboratory (LH) and the Center for Research in Clinical Biochemistry and Immunology (Cibici – UNC / CONICET), of the Faculty of Chemical Sciences, in Argentina all these institutions. The procedures for processing the patent were carried out by the UNC Intellectual Property Office.
The synthetic molecule functions as an essential reagent in the execution of techniques that allow the detection of viral genomes and are applied in the production of medicines derived from human plasma.
This technological advance not only guarantees the biological safety of these medications, but also strengthens the sustainability and sovereignty of the Argentine national industry, since this compound had to be imported.
The Argentine National Institute of Industrial Property granted UNC and CONICET (National Council for Scientific and Technical Research) an invention patent for the development of a synthetic ribonucleic acid (RNA) molecule, which is used for the detection of HIV type 1 and hepatitis C in human serum and plasma. Those in charge of its development have already demonstrated that it is also applicable to hepatitis A and E viruses, as well as human tissues.
In the university laboratory, this molecule is currently used as an internal control reagent in molecular biology techniques (such as PCR and real-time PCR) to guarantee the biological safety of products derived from human plasma.
The development of the reagent is the second invention patent that the Laboratory of Blood Products obtains for the National University of Córdoba. The first was for the procedure to obtain human immunoglobulin G and its preparation as a medication for intravenous application.
Laboratory work. (Photo: National University of Córdoba / Argentina Investiga)
The origin of the patent
“The objective was not to make a patent, but rather it was the consequence of a need for the Laboratory. In 2008 we needed a reagent to guarantee the quality of the results obtained by molecular biology techniques intended for the detection of viral genomes, in this case, related to the pharmaceutical industry and blood banks,” Gonzalo Rodríguez Lombardi, explains to Argentina Investiga, deputy director of the Product and Process Development Area of the LH and one of the people who developed the patent.
“Our plant produces medicines derived from blood. Any pathogen present in the blood is a potential risk for the industry and, therefore, for human health. That is why we must apply various techniques to detect the genomes of the viruses that interest us. And to execute them it is necessary to implement quality controls in accordance with international standards,” Rodríguez-Lombardi completes.
This required a specific reagent that was not produced in Argentina. The cost of importing it was very high and the solution was to produce it locally. The Blood Products Laboratory and the Research Center in Clinical Biochemistry and Immunology (UNC/Conicet) of the Faculty of Chemical Sciences faced the challenge and developed it.
“The idea was to make one hundred percent national development between both agencies. We agreed to do something together that would have an industrial application,” summarizes Rodríguez-Lombardi.
Technological development represents a highly relevant advance for the university laboratory. It allows you to have an essential input for the control and compliance with the quality requirements that guarantee biological safety in the production of medicines derived from plasma, in accordance with international requirements.
In their genomic structure, viruses can be of two forms: contain DNA or RNA. Among the latter are hepatitis A, C and E, HIV, and even SARS-CoV-2 (coronavirus). As can be seen, the application of the reagent is broad.
“We originally created it to detect HIV and hepatitis C. We later extended it to hepatitis A and E. We think that in the future we can extend it to other RNA viruses,” says Rodríguez-Lombardi.
For now, the development has already transcended the walls of the Blood Products Laboratory and is also used by the José María Vanella Institute of Virology, of the Faculty of Medical Sciences (UNC).
“At that institute they carry out studies of environmental virology, health and food safety. They use the molecule as an internal control for the detection of the hepatitis A virus in water, and the detection of the hepatitis E virus in fish meat, pork and pork derivatives, such as sausages,” says Rodríguez-Lombardi. In this way, what was initially intended for the pharmaceutical industry was later found to have other applications.
Hemoderivados has the mission of producing medicines within the reach of the population and carries out its work on a non-profit basis, which is why it acts as a regulator of local market prices. In this scenario, technological development was conceived to guarantee the biological safety and quality of its products, but was later extended to other departments. “The idea is to offer it especially to all the public sphere that needs it,” they point out from the university laboratory.
“The technological development is sustainable, very low cost and with notable productive performance under the defined conditions of its use. It has great versatility and potential for use – as explained in detail in the invention patent –, which allows it to be applied in any molecular analysis platform that involves RNA as a molecule of interest,” Rodríguez-Lombardi completes.
About the patent
The patent “Synthetic ribonucleic acid molecule used as an internal control in the development of genome amplification techniques for the detection, identification and semi-quantification, simple and multiple, of viral ribonucleic acids” was requested on December 20, 2011 by the National University of Córdoba and the National Council for Scientific and Technical Research (Conicet).
On November 30, 2022, the National Institute of Industrial Property granted the invention patent for a period of 20 years. For this achievement, the efforts of the Intellectual Property Office of the Secretariat of Innovation and Technological Linkage of the UNC were crucial.
This patent becomes Hemoderivados’ second contribution to the UNC invention patents. The previous one was the invention patent “Procedure for the production of intravenous human immunoglobulin G”.
The team responsible for this technological development is made up of Gonzalo Rodríguez-Lombardi, Susana Genti-Raimondi, María Susana Vitali and Luciana Reyna. (Source: Soledad Huespe / National University of Córdoba / Argentina Investiga)
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