An Australian ‘convalescent plasma’ product is to be developed by CSL with the aim of using anti-SARS-CoV-2 immunoglobulin to prevent people with COVID-19 from advancing to more severe disease.
The investigational product, to be known as COVID-19 Immunoglobulin, will be developed by CSL Behring Australia at its manufacturing facility in Victoria from the plasma of people who have recovered from COVID-19.
CSL says the first phase of the development program will see a small batch of COVID-19 Immunoglobulin 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.
Plasma from people who have recovered from COVID-19 will contain high level of antibodies that will pooled, purified and concentrated to make COVID-Immunoglobulin – also known as a hyperimmune globulin. These donations will be collected by the Australian Red Cross Lifeblood.
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.
“We are very proud to be part of this initiative which may ultimately help treat patients suffering from this terrible disease,” said Shelly Park, Chief Executive of Lifeblood.
“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.”
CSL says that if the clinical trial is successful, it will seek to register COVID-19 Immunoglobulin with the TGA to allow its ongoing supply in Australia.
“Our efforts will leverage the full spectrum of our onshore capabilities, from research and development, through to advanced manufacturing,” said CSL’s Chief Medical Officer, Dr Charmaine Gittleson.