On January 25, 2021, the first industrial load of plasma with antibodies against COVID-19 in the amount of 2,100 liters took place at the modern pharmaceutical plant Biopharma. The plasma was collected in company`s plasma centers for the production of hyperimmune immunoglobulin
The supply of the product to the finished goods warehouse is expected at the end of February. Further, the drug will be tested in an independent French laboratory, which is expected to confirm its antiviral activity in March. If the conclusion of the European laboratory is positive, Biopharma will be able to start clinical trials of the anticipated drug in Ukraine.
The collection of plasma with antibodies against COVID-19 started in the spring of 2020 in cooperation with the CoVIg-19 Plasma Alliance. The goal of the alliance is to accelerate the development and provide reliable and sustainable treatment for people with severe coronavirus disease.
In October 2020, within the framework of the alliance, the third phase of a clinical trial of inpatient treatment with hyperimmune immunoglobulin was launched. The study is funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is the part of the National Institutes of Health (NIH) in the USA. This global multicenter, randomized study includes 500 adult patients at 58 sites in the United States, Mexico and 16 other countries on five continents.
The study results are planned to be published in April 2021. If the trials are successful, the new treatment could provide hope for those suffering from serious health effects caused by COVID-19.
“As of today, thanks to the concerned donors in Ukraine, we managed to collect about 10,700 liters of plasma from those who had recovered from COVID-19. This amount of plasma will save hundreds of lives of Ukrainians. We thank each donor, who shared their antibodies to help severely ill patients. And we continue to encourage everyone concerned to become plasma donors in order to create vital drugs,” company`s CEO Kostiantyn Yefymenko said.
*** Plasma Alliance CoVIg-19
In an effort to help fight the COVID 19 pandemic, the Alliance was formed in April 2020 to help develop potential plasma-derived therapy for people at risk of serious complications from COVID 19. CoVIg 19 Plasma Alliance brings together 10 world-leading plasma companies. The goal of the partnership is to work on the development of an investigational unbranded polyclonal anti-SARS-CoV-2 hyperimmune globulin medicine with the potential to treat patients who are at risk for serious complications from COVID-19.
The hyperimmune globulin is a high-quality pharmaceutical product that contains purified, consistent, and concentrated levels of convalescent antibodies. The “I” and “g” in CoVIg-19 stand for immune globulin, which the CoVIg-19 Plasma Alliance will use to concentrate the antibodies into a potential medicine. The Alliance, formed by CSL Behring and Takeda, also includes the leading-edge expertise of founding members Biotest, BPL, LFB, and Octapharma, and the additional industry members ADMA Biologics, Biopharma, GC Pharma, Liminal BioSciences, National Bioproducts Institute and Sanquin. The Bill & Melinda Gates Foundation provides advisory support. Microsoft provides technology including the Alliance website and the Plasma
Bot for donor recruitment. Organizations including Pall and Uber Health also contribute to the CoVIg-19 Plasma Alliance. Experts from the Alliance cooperate on such key aspects as plasma collection, clinical trial development and conduction, and product manufacturing.
It is a Ukrainian biopharmaceutical company specializing in the development and production of innovative high-tech drugs from human donor blood plasma. The company is also actively involved in the development of plasma centers and donor movement in Ukraine.
In 2019, the company put into operation a state-of-the-art fractionation plant in Bila Tserkva (Kyiv region), which uses the latest production technologies. Investors used $ 75 million of their own and credit funds to build and commission production.
Among other things, the company has attracted investment by selling pharmaceutical production facilities to the STADA group of companies, which is a global manufacturer of high-quality generic drugs and consumer health products. Biopharma shareholders, in their turn, focused on developing the production of drugs from human donor plasma. The plant manufactures a wide range of innovative drugs. The drugs include: factor VIII – a vital drug for patients with hemophilia; Albumin – a drug for recovery and maintenance of blood circulation volume during injuries and surgeries; immunoglobulins – blood proteins that are widely used to enhance the body’s ability to resist disease.
The company also develops regional blood centers, promoting donation. Today regional plasma centers of Biopharma Plasma operate in Kyiv, Dnipro, Kharkiv, Cherkasy, Sumy, Konotop and Shostka. The company’s investment in this area amounted to more than 10 million dollars.