CSL competitor eyes commercialisation in plasma production market

Biotech News: In the midst of a worldwide shortage of therapeutic plasma products, Australian biotechnology company, Aegros, is set to reshape the market. With CSL as its primary competitor, Aegros is one of only two companies permitted to manufacture therapeutic plasma in Australia.

Over the past decade, Australia has witnessed a gradual decline in its self-sufficiency of plasma, attributed to CSL’s challenges in increasing process yields. Currently, 100% of the plasma collected by Lifeblood (Red Cross) in Australia is directed to CSL for processing under an agreement managed by the National Blood Authority (NBA).

Aegros, seizing the opportunity to address the pressing demand for therapeutic plasma, is currently preparing a submission to the Australian Register of Therapeutic Goods for its first therapeutic product, Covimmune. Simultaneously, it is finalising the upgrade of its dedicated hyperimmune production facility in anticipation of commercial sales.

Like CSL attempted, Aegros’ COVID-19 hyperimmune treatment has been developed through harnessing antibodies from recovered COVID-19 patients. Rather than using it as treatment for patients sick with COVID-19 like CSL tried, Aegros believes the hyperimmunes will be more effective as a preventative measure.

The company is constructing a 1 million-litre Haemafrac facility, supported by the Queensland Government. This production facility, slated to commence operations in 2026, boasts Good Manufacturing Practice (GMP) licensing and promises to elevate process yields to over 85%, thereby reducing costs, carbon emissions, and enhancing product safety. Aegros intends to produce Albumin, IVIG, and various plasma products for both the Australian and global markets.

The company has also recently appointed industry veterans to its Strategic Advisory Committee (SAC), including Jan M Bult, former President and CEO of the Plasma Protein Therapeutics Association, as Chair, and Gayle Ginnane, former Chair of the National Blood Authority, as a committee member.

“Aegros and its Haemafrac technology bring something completely new to the plasma sector, and I am looking forward to ensuring that its therapies, processes, and technologies are given every chance to succeed in a sector that still relies on old technology,” stated Mr Bult.

Ms Ginnane highlighted “With demand growing both here and abroad at around 8%, Australia and the world needs a new supplier to meet current and future blood product needs. I look forward to being a part of its exciting and emerging leadership with its yield-leading Haemafrac process and bringing new therapies to market.”

According to the NBA’s annual report, in 2020 CSL charged the NBA $426m to provide plasma products, with a further $44m provided by Grifols. CSL charged an additional $42m to process free Lifeblood supplied plasma compared to products supplied using its overseas plasma.

Aegros aims to address inefficiencies in the current plasma industry. The Haemafrac technology can yield 8g of immunoglobulin (IgG) per litre of plasma compared to CSL at 5g per litre. The company, currently sourcing plasma from the US, plans to establish a local supply for its Queensland facility once the NBA agreement with CSL expires in 2026. Aegros anticipates that collaboration with the NBA will enhance Australia’s plasma production capabilities and reduce costs.

John Manusu, Co-founder of Aegros, expressed confidence in the potential of their hyperimmune treatment, stating, “Based on the previously released interim clinical trial results of our hyperimmune against COVID-19, and the progress of the upgrade to our dedicated hyperimmune facility, we are ready for commercial operations.”

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