In a signature moment for Aegros, a signing ceremony took place today, to formalise a contract to supply 100,000 litres/yr of convalescent blood plasma for the manufacture of Aegros Covid-19 hyperimmune.
The agreement is for the supply of US sourced convalescent plasma. The Founders of Aegros previously ran a US plasma collection business, and it’s their knowledge which has enable Aegros to obtain this rare plasma.
Caption: Aegros Board members John Manusu, Janet Bowen & Professor Hari Nair celebrate signing a contract for the supply of convalescent plasma.
Aegros’ fractionation facility at Macquarie Park, NSW is currently being upgraded; which will lift its plasma fractionation capacity from 30,000L to at least 100,000L per annum, and now Aegros has secured the plasma supply it needs for its commercial operations.
The upgrade to the Macquarie Park facility is expected to conclude before the end of the 2023 calendar year, which is when the new eight cartridge HF-02 HaemaFrac® will be installed, validated, and ready to manufacture the Covid-19 hyperimmune.
The blood plasma secured under this contract provides the plasma for Aegros to manufacture its hyperimmune against Covid-19.
In a sign of Aegros’ capability to make therapeutic products, successive batches of this hyperimmune against Covid-19 have already been produced in 2022 and in 2023, using Aegros’ two cartridge HF-01 HaemaFrac®, with product from these batches used in the clinical trial, kept on hand for stability trials and other analytical purposes.
As previously reported the 3 sentinel clinical trial participants were successfully dosed. The results of the sentinel group is now before the Human Ethics Committee for review. Recruitment has begun for the remaining 12 clinical trial participants, and Aegros looks forward to sharing further news about this clinical trial soon.
Once the clinical trial is concluded, Aegros will apply to have its Covid-19 hyperimmune included on the Australian Register of Therapeutic Goods (ARTG), which is a prerequisite for commercial sales to begin.
Aegros has taken a sound and secure approach to its clinical trial and will continue in the same vein for the development of all therapeutic products.
But once that ARTG listing has been secured for Aegros’ first product, it is good to know the Company secured supply of the critical rare Covid-19 convalescent blood plasma it needs to make the product, thereby providing the benefits of passive immunity against Covid-19 to those who need it.
Today’s signing ceremony is further confirmation that Aegros is a leading-edge fractionator in this global market and will soon become an important participant in Australia’s plasma-derived medicinal landscape.