Aktualizacja: 19 sie 2020
When will a cure for coronavirus be developed?
"We have a unique chance for the Polish company to be the first in the world to produce a drug from the plasma of convalescents," argued Piotr Fic, member of the management board for operational matters at Biomed Lublin SA, in an interview with 'DZ' at the end of June. On August 18, Biomed SA announced at a press conference that the production of the first batch of Polish anti-COVID-19 drug from the plasma of convalescents was launched. The company has a patented technology for isolating antibodies from it and state money to create a pioneering drug. It is ready to start production. We recall our conversation with Piotr Fice from Biomed Lublin SA.
The SARS-CoV-2 vaccine will be ready for administration to those exposed most likely in the new year. The number of people infected in the world is constantly growing, and experts are increasingly announcing another wave of cases in Poland in the fall. Therefore, scientists from different parts of the globe are feverishly working on creating a preparation that would aid the treatment of people infected with the virus.
Biomed Lublin, in cooperation with the Independent Public Clinical Hospital No. 1 in Lublin, the Institute of Hematology and Transfusion Medicine and the Medical Research Agency, also stood in this race. At some point, however, work slowed down. Mainly due to the insufficient number of plasma donors and the procedure for its collection. The one used by the blood donation centers differed from that used in the manufacture of the drug. Piotr Fic, member of the management board for operational matters at Biomed Lublin S.A., talks about the stage of work in the development of the Polish drug for Covid-19.
At one point, the company could not start the production of the drug due to the lack of plasma of convalescents. Has this issue been resolved?
Piotr Fic states that ''the management of the National Blood Center informed us last Thursday that the Minister of Health agreed to the possible cooperation of regional blood donation centers with Biomed Lublin in the scope of the project, which means that RCKiK can start collecting plasma from convalescents according to a procedure in accordance with the manufacturer's requirements, i.e. Biomed Lublin. Talks are currently underway to clarify the details of the so-called quality agreement between RCKiKs and our company, based on which the centers will be able to transfer the collected plasma to the company.''
So at what stage are the works related to the development of the Polish drug for Covid-19?
''First, we have to obtain from RCKiK a minimum of 150 liters of plasma from convalescents, meet the requirements of the manufacturer, from which the company will produce the first batch of the drug for clinical trials. The production process will take about 1.5 months, which means that we should have the drug ready in mid-September. Then, the manufactured product must be tested by the Institute of Hematology and Transfusion Medicine, which may take another 1.5 months. After the so-called when a product is released for research, clinical trials will take four months. After summarizing the results, assuming that these confirm the drug's effectiveness, anti-SARS-CoV-2 immunoglobulin must be registered by the Drug Registration Office and authorized for marketing. The registration process takes approximately 210 days according to standard procedures. So the speed of the registration process, which we hope will be given the highest priority, will determine when the drug is released for sale. RCKiK influences the amount of collected plasma. We will learn about the quality of plasma from convalescents, i.e, the level of antibodies contained in it, after receiving the first batch. Our priority is the Polish market. At the moment, no one is thinking about foreign markets, as Polish patients are the most important.''
What production volume do you predict?
''The production volume depends on two main factors: the first is the amount of plasma collected, and the second is the titer, i.e, the concentration of antibodies in the plasma from convalescents that Biomed Lublin will receive for the production of the drug. From 150 liters, the company can produce approx. 3,000 ampoules as a standard. Only clinical trials will show how many ampoules will constitute a therapeutically effective dose. The efficiency of the production process depends on the concentration of antibodies in the plasma, because each ampoule of the produced drug must contain the same amount of antibodies. Thus, the more high-titer plasma, the more Anti-SARS-CoV-2 Immunoglobulin can be finally produced. Initially, we are able to produce 30-35 thousand. doses per year.''
Will the Polish drug for Covid-19 be relevant if other drugs appear on the market earlier?
''Currently, there are millions of people suffering from COVID-19. Even if some manufacturer produces the drug earlier than us, it will not be able to cover the demand. Being the first is a matter of ambition, because we have a unique chance that a Polish company will be the first in the world to produce a drug from the plasma from convalescents, Polish scientists were the first in the world to test this drug in Poland and a message was issued that it helps to fight coronavirus. If Biomed Lublin is not the first, domestic production will still be used to save patients in Poland. Having its own source of the drug, Poland will become independent from foreign suppliers, for whom the priority will be their markets and those of which the price of the drug will give them greater profits.''