CSL Behring Australia, a subsidiary of CSL Limited, today 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.
CSL Behring’s immediate research involves two phases. In the first phase, 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 (proteins that fight COVID-19) in their plasma (the liquid part of their blood), and these antibodies will be pooled, purified and concentrated to make COVIDImmunoglobulin – also known as a hyperimmune globulin. These donations will be collected by the Australian Red Cross Lifeblood (Lifeblood).
The Hon. Greg Hunt Commonwealth Minister for Health said, “Australia is playing an important role in the battle against COVID-19. 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.”
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.
Shelly Park, Chief Executive of Lifeblood said, “Developing this new treatment requires plasma donations from people who have fully recovered from COVID-19, and whose plasma contains high levels of antibodies that can fight the SARS-CoV-2 virus that causes COVID-19. We are very proud to be part of this initiative which may ultimately help treat patients suffering from this terrible disease. 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 to allow its ongoing supply in Australia.
CSL’s Chief Medical Officer, Dr Charmaine Gittleson said, “With a 104 year heritage of serving Australia’s health needs, CSL is very pleased to be able to play a role in the response to the current pandemic. Our efforts will leverage the full spectrum of our onshore capabilities, from research and development, through to advanced manufacturing.”
Development of a COVID-19 Immunoglobulin from plasma donated in Australia is one of many approaches CSL is exploring to help combat the COVID-19 global pandemic. CSL is part of a previously announced worldleading global alliance formed with other companies that manufacture plasma products. The global alliance is also focused on developing and delivering a COVID-19 immunoglobulin product. The Australian-based project announced today will take advantage of all possible synergies with the global Alliance project as well as contribute any resulting data from the Australian clinical study to the international effort.”
CSL Behring will work with the National Blood Authority, a statutory agency representing the Australian Commonwealth Government and State and Territory governments, to develop COVID-19 Immunoglobulin for Australia’s population. In recognition of the public health crisis precipitated by COVID-19, CSL Behring Australia will undertake the development of COVID-19 Immunoglobulin at no cost to Australian Governments.