PERTH, Australia – Melbourne-headquartered CSL Behring Australia, a subsidiary of CSL Ltd., will begin developing an anti-SARS-CoV-2 plasma product to treat people with serious complications of COVID-19 in Australia.

COVID-19 Immunoglobulin will be developed by CSL Behring Australia at its manufacturing facility in Broadmeadows, Victoria.

“This is an important step forward as we develop tools in the arsenal to fight COVID-19,” said CSL Ltd. Chief Medical Officer Charmaine Gittleson during a May 6 press conference.

Although the Australian government has made fantastic efforts in flattening the curve and in reducing community spread of the virus, it is “important that we are ready as a country for a second wave,” she said.

A small batch of COVID-19 Immunoglobulin will first be produced to develop tests that detect the presence of the antibodies that fight the SARS-CoV-2 virus. The second phase will involve a larger batch of COVID-19 Immunoglobulin that will be used in clinical trials in Australia.

The product will be developed using donations of plasma made in Australia by people who have recovered from COVID-19 as those donors have a high level of antibodies in their plasma. The antibodies will be pooled, purified and concentrated to make COVID Immunoglobulin. Donations will be collected by the Australian Red Cross, Lifeblood.

“CSL Behring’s manufacturing facility will be one of the first in the world to commence development of a COVID-19 immunoglobulin,” said Health Minister Greg Hunt.

“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,” said Gittleson, noting that, in 1916, CSL made 3 million doses of vaccine for the Spanish flu.

CSL makes numerous hyperimmune products at its Broadmeadows facility, and COVID-19 Immunoglobulin will be made using known validated processes, she said.

Treatment for serious cases only

She stressed that COVID-19 Immunoglobulin is a treatment – not a vaccine – that will be used in patients with serious cases who are starting to develop difficulty breathing. That happens when the virus infects the lungs and begins to destroy lung cells. If the body isn’t able to control the virus at that stage, the patient is at high risk of developing acute respiratory distress syndrome (ARDS) whereby the immune system goes into overdrive and a cytokine storm develops.

At that stage, patients need to go into intensive care units and become ventilated, Gittleson said, stressing that once ventilated, those patients have a very poor prognosis.

“The hope is that we can treat those patients earlier and prevent them from reaching this intensive stage. If we’re able to boost their immune systems with a hyperimmune globulin, the hope is the COVID-19-specific antibodies will bind to the virus and neutralize it to aid in recovery.”

She said a hyperimmune product could potentially be used as a preventive treatment for people who have been exposed and are being continuously exposed, such as health care workers.

CSL Behring will work with the National Blood Authority to develop COVID-19 Immunoglobulin for Australia’s population. CSL Behring Australia said it will develop the product at no cost to the Australian government.

Roughly 800 plasma donations will be required to produce sufficient COVID-19 Immunoglobulin to treat 50 to 100 seriously ill people under the clinical trial.

Convalescent plasma is being used in trials in many countries around the world, including Canada, the U.S., the U.K. and China, said James Daly, medical director of Lifeblood’s pathology services. And Lifeblood will be joining that work and collecting convalescent plasma.

“As Australia’s sole supplier of plasma, we’re in a unique position to help, and we’ll be able to collect large volumes of plasma starting next Monday.”

Daly said there are already about 100 donors who have had COVID-19, and there are more than 5,500 people in Australia who have recovered and would be eligible to donate their plasma.

The hyperimmune product will provide a “consistent scalable approach,” said Gittleson, but the first trials will be with convalescent plasma before the hyperimmune product is manufactured.

She said the trials will be masked trials, randomized with standard-of-care treatment, but they won’t be blinded as the clinicians will know who is receiving which treatment.

Development of a COVID-19 Immunoglobulin from plasma is one of many approaches CSL is exploring to help combat the COVID-19 global pandemic. CSL is also part of a global alliance with other companies that manufacture plasma products to develop a COVID-19 immunoglobulin product, she said.

“The Australian-based project 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,” Gittleson added.

Even so, that effort in Australia is for Australia to be self-sufficient, she said, stressing that the Australian project was a completely separate one from the larger global alliance.

If the trial is successful, CSL Behring will seek to register COVID-19 Immunoglobulin with the Therapeutic Goods Administration to allow its ongoing supply in Australia. She said a product could potentially be developed by the end of the year.

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