(QCOSTARICA) The first two batches of a potential drug to treat COVID-19 produced by the Clodomiro Picado Institute of the University of Costa Rica (ICP-UCR) are ready for quality control tests.
The treatment was obtained through the inoculation of proteins against the virus in horses, from which a product known as equine immunoglobulins (antibodies) was obtained.
The batches consist of a total of 1,000 injection bottles and contain antibodies against two different combinations of proteins from SARS-CoV-2, the virus that causes COVID-19.
If this drug were to prove safe and effective, it would be used as a serum in people who are hospitalized with COVID-19. This is one of the three options in which the ICP-UCR works together with the Caja Costarricense de Seguro Social (CCSS). The other two are using plasma from recovered patients, and purifying this plasma and creating specific sera with the antibodies found in the plasma.
At the moment, the data on the equine immunoglobulins already register good results.
“The previous data we have indicate that the formulations comply with the design that we had established,” said Guillermo León Montero, coordinator of the Industrial Division of ICP-UCR.
At this time, the formulations are undergoing quality control tests. One of them is the so-called sterility test, which aims to ensure that this serum is safe for patients.
After this step, it can be sent to the CCSS for use in patients with COVID-19.
The studies are being carried out by the Pharmaceutical Analysis and Advisory Laboratory of the Faculty of Pharmacy of the UCR (Layafa-UCR).
“This quality test seeks to demonstrate the safety of the product in terms of verifying the absence of aerobic bacteria, fungi, and yeasts.
“The test is very important because, if a product with some contamination is applied to the patient, it can produce sepsis and endanger their life,” said Jeimy Blanco Barrantes, coordinator of the Laboratory.
Quality control is not the only exam that this product must pass.
In the United States, the George Mason University is analyzing whether the formulations proposed by Costa Rican scientists inhibit the infectious power of the SARS-CoV-2 virus in culture cells.
If the test is passed, the ICP-UCR will send the formulations to the CCSS, which will carry out a clinical study to conclusively determine if the formulations made are effective and safe for the treatment of patients with COVID-19.
“The formulations have high concentrations of antibodies against viral proteins. In fact, they have significantly higher concentrations than the plasma of convalescent patients. However, only the clinical study will tell if the formulations are effective, “emphasized León.