LEI; Authorized Third Party That Responds to The PandemicBy Miriam Bello | Wed, 05/27/2020 - 17:00
Amid the COVID-19 global pandemic, the healthcare sector faces an urgent challenge that demands all actors in the industry join efforts to successfully conquer the health emergency. “COVID-19 quickly became a problem for healthcare systems around the world. Once it became a pandemic, it was clear that the whole healthcare industry had to cooperate and contribute, including both public and private entities,” says Cecilia Padierna, Director of the New Business Development at LEI.
Laboratorios de Especialidades Inmunológicas (LEI), a third party authorized by COFEPRIS, is developing a portfolio of services in response to the pandemic. “Our integral portfolio offers high-quality services with the scientific support of high-level professionals and state-of-the-art technology,” says Padierna. LEI is characterized by its innovative catalog of research tools and solutions for the pharmaceutical, human and veterinary segments. Building on its good reputation and complete portfolio, LEI decided to adapt its tools to offer polymerase chain reaction (PCR) tests for detecting COVID-19. PCR tests have been highly recommended by WHO because they detect the actual activity of the virus, determining if the person is infected. Padierna highlights LEI’s collaboration with the Institute of Epidemiological Diagnosis and Reference (InDRE), which allowed the company to offer these tests after the institute recognized LEI’s previous work on positive controls and solutions.
LEI also runs verification on diagnosis kits, which serves as a way to verify the specificity and sensitivity of antigen and antibody detection kits. These services complement the company’s biocompatibility tests of medical devices, which provide results related to the biocompatibility analysis panel of medical devices used to treat seriously ill patients infected with SARS-CoV-2. LEI carries out the tests in 3D in-vitro systems that reduce the time of analysis.
Regarding sanitizers, LEI studies the viricidal activity of products. The company’s last two services oriented to COVID-19 are preclinical evaluation of antivirals and the determination of immunogenicity of vaccines. These last services run immunogenicity tests on potential vaccines, measuring the number of antibodies and the constants of binding and affinity through the resonance of superficial plasmons. Results are reported to COFEPRIS as a way to cooperate and help during the current crisis.
Padierna says that the reception of these products has been good and that the company is happy to have been actively able to help the Mexican population and the authorities through LEI’s knowledge and experience. She adds that “the current context will lead to developments in the field of pharmaceutics and biotechnology, which presents an opportunity for LEI in its future work as an authorized third party for COFEPRIS.”
Innovation and technology are banners for LEI. Its technological management model, supported by consolidated tools for the development and quality control of advanced therapies, allows the company to actively participate in the battle to control the pandemic. “This puts us one step ahead by offering the SARS-CoV-2 and viricidal activity tests, which are of the utmost importance in providing quality and scientific certainty for the benefit of tomorrow,” says Padierna.
LEI is focusing all its efforts on the COVID-19 fight. “COFEPRIS’ workload is saturated with medical supplies and medical devices, which are urgently needed to prevent an overburdening of the Mexican healthcare system. Being an ally of COFEPRIS will help avoid delays in regulatory process regarding SARS- CoV-2,” Padierna says.