Antibody product to treat serious cases of COVID-19
CSL Behring Australia, a subsidiary of CSL Limited, has announced that it will begin immediate onshore development of an anti-SARS-CoV-2 plasma product with the potential to treat people with serious complications of COVID-19 — particularly those whose illness is progressing towards the need for ventilation.
The investigational product, to be known as COVID-19 Immunoglobulin, will be developed by CSL Behring Australia at its advanced manufacturing facility located in Broadmeadows, Victoria. As noted by Minister for Health Greg Hunt, “CSL Behring’s manufacturing facility will be one of the first in the world to commence development of a COVID-19 immunoglobulin that may provide benefit to seriously ill Australians in need of treatment.”
In the company’s first phase of research, a small batch of COVID-19 Immunoglobulin will be produced and used to develop tests to detect the presence of the antibodies that fight the SARS-CoV-2 virus that causes COVID-19. The second phase will involve a larger batch of COVID-19 Immunoglobulin that will be used in clinical trials in Australia’s hospitals to establish the safety of the product.
The product will be developed using donations of plasma made in Australia by people who have recovered from COVID-19. These donors have a high level of antibodies in their plasma, and these antibodies will be pooled, purified and concentrated to make COVID-Immunoglobulin — also known as a hyperimmune globulin.
It is estimated up to 800 plasma donations will be required to produce sufficient COVID-19 Immunoglobulin to treat 50–100 seriously ill people under the clinical trial. Donations will be collected by the Australian Red Cross Lifeblood, with Chief Executive Shelly Park saying, “I would encourage anyone who has recovered from a confirmed case of COVID-19 who thinks they may be eligible to donate to contact us.”
If the clinical trial is successful, and subject to request by Australian governments, CSL Behring will seek to register COVID-19 Immunoglobulin with the Therapeutic Goods Administration (TGA) to allow its ongoing supply in Australia. The company plans to work with the National Blood Authority, a statutory agency representing the federal, state and territory governments, to develop COVID-19 Immunoglobulin for Australia’s population.
CSL is also part of the global CoVIg-19 Plasma Alliance with other companies that manufacture plasma products — an alliance which is similarly focused on developing and delivering a COVID-19 immunoglobulin product. The Australian-based project will take advantage of all possible synergies with the alliance’s project as well as contribute any resulting data from the Australian clinical study to the international effort.
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