The Clodomiro Picado Institute of the University of Costa Rica (ICP-UCR) has already successfully packaged the first two batches of equine immunoglobulins with which it is intended to treat seriously ill patients with COVID-19. The batches consist of a total of 1,000 vials and contain antibodies against two different combinations of SARS-CoV-2 proteins.
“After several months of work, we have finally managed to package the equine immunoglobulin formulation. The process occurred as scheduled. The previous data that we have indicate that the formulations comply with the design that we had established, ”said Dr. Guillermo León Montero, coordinator of the Industrial Division of ICP-UCR.
Now one of the strictest stages of the process follows: quality control. The formulations are currently undergoing a series of rigorous analyzes including the sterility test.
The purpose of the sterility test is to ensure that the serum is safe for patients before sending it to the Costa Rican Social Security Fund (CCSS). On this occasion, the study is being carried out by the Pharmaceutical Analysis and Advisory Laboratory of the Faculty of Pharmacy of the UCR (Layafa-UCR).
For more than 15 years, Layafa-UCR has contributed with the Ministry of Health in the task of ensuring that the drugs marketed in the country meet all the criteria of quality, safety and efficacy.
“We are running the sterility test for two batches of equine immunoglobulins manufactured by the ICP-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 her life, “said Dr. Jeimy Blanco Barrantes, coordinator of the Laboratory.
In addition to the above, George Mason University, in the United States, is also analyzing whether the formulations proposed by Costa Rican scientists inhibit the infectivity of the SARS-CoV-2 virus in culture cells.
If all of the above is successfully completed, what follows is the official submission of batches to the CCSS. The results of the clinical study to be carried out by the Fund will determine, conclusively, whether the formulations carried out are effective in treating patients with COVID-19.
“The effort has been great and we have obtained the fruits that we had programmed. 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 Dr. León.
The entire team of the UCR Clodomiro Picado Institute participated in this work, which includes the staff of the bioterio, serpentarium, stables, production, quality control, technological development, research and administrative area.