In April 2020, CSL Behring joined with other leading biotech companies to form the CoVIg-19 Plasma Alliance dedicated to fighting the coronavirus. The aim of this alliance is to work together to develop a plasma-based treatment for patients with severe COVID-19 complications. Joint resources, shared knowledge, and a coordinated approach help create new solutions and accelerate the development of plasma-based therapies.
Antibodies as the basis for treatment
The CoVIg-19 Plasma Alliance uses antibodies formed in the blood of recovered COVID-19 patients to develop this potential treatment. There has been an increased call for plasma donations for several weeks so as to be able to use these antibodies to develop a drug.
Two promising therapeutic approaches
In the direct transfusion procedure, the donated plasma is first tested for compatibility between the recovered donor and the patient. The plasma is also examined to ascertain whether it contains sufficient coronavirus antibodies, as the number of antibodies varies depending on the donor. If these conditions are met, the plasma can be administered directly to patients with severe COVID-19 complications in the form of a transfusion.
In the second procedure, plasma-based therapy, donated plasma is purified to eliminate pathogens such as viruses and processed to produce hyperimmune globulin. Hyperimmune globulins are antibodies that target specific pathogens. These hyperimmune globulins provide the basis for a potential COVID-19 drug. After extensive testing, the therapeutic agent must be approved by the authorities before it can be used for treatment.
The approval timeline of the drug is subject to a number of factors. The Paul Ehrlich Institute, which is responsible for the approval and release of biomedical drugs in Germany, has allowed a simplified, accelerated approval process to be used as all the companies involved in the CoVIg-19 Plasma Alliance already have experience in the use of hyperimmune globulin preparations.
If international regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), also confirm the safety and efficacy of the plasma-based therapeutics, there could be a COVID-19 treatment in use before the end of the year.