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The Management Board of Biomed Lublin informed about the conclusion of contracts for the supply of plasma containing anti-SARS-CoV-2 antibodies. As of 20 July 2020, the contract in this area was signed with nine Regional Blood Donation and Blood Management Centres (RCKiK). There are still no contracts for nearly 66 litres of plasma to begin work on fractionation.
Nine contracts cover more than half of the plasma needed
According to Biomed Lublin in its current report, 84.055 litres of plasma containing anti-SARS-CoV-2 antibodies have been collected under the concluded contracts, which requires additional testing by an external laboratory for antibody levels. So far 34,932 litres of plasma have been tested.
The first deliveries are to start today. Biomed Lublin will inform about the collection of a full pool of plasma allowing to start the process of production of Immunoglobulin against SARS-CoV-2.
Immunoglobulin against SARS-CoV-2
A minimum of 150 litres of plasma is required to start plasma fractionation and produce Immunoglobulin against SARS-CoV-2. The company states that the production process itself will take about 1.5 months. Then the manufactured product must be examined by the Institute of Haematology and Transfusionology, which may take another month or 1.5 months.
The next stage is clinical trial, which according to Biomed Lublin estimates may take about 4 months. Then, if all the tests are positive, in order for the product to be legally authorised, Immunoglobulin against SARS-CoV-2 must be registered by the Office for Registration of Medicinal Products and Biocidal Products.