Aegros’ production facility, located in Macquarie Park Sydney where its innovative HaemaFrac® technology is housed, and where Aegros is making its Covid-19 hyperimmune product, today received its Good Manufacturing Process (GMP) accreditation from the Therapeutic Goods Administration (TGA).
The milestone means Australia now officially has a new fractionator within its borders, adding capability, structural resilience, and enhanced best practice governance to the management of plasma-derived medicinal products (PDMPs), a critical health resource sourced from blood plasma.
The importance of this achievement is not to be underestimated.
Since the 1940s PDMPs have been made using the Cohn Process fractionation method. Despite 70+ years of utilisation and refinement, the Cohn process is only able to achieve yields of around 50%. Cohn processing is energy intensive, expensive, takes a long time, and destroys close to 50% of the valuable blood plasma it processes due to ethanol exposure through a 10+ step protein capture methodology.
By way of contrast, the HaemaFrac® has yields that start at 90%, has faster processing times, uses less energy, has exceptional purity, and, as it uses no ethanol or other solvents, does not destroy the source blood plasma, thanks to its bio-separation and capture in a single process step.
This accreditation caps off a near 30 year journey as the HaemaFrac® technology grew from idea to prototype, from desk scale to production scale.
Aegros thanks all who have contributed to this amazing technological journey over that time frame. More information about the history and timeline of Aegros’ development, and that of the HaemaFrac®, is available.
Accreditation Is Good News For Replications Too
The TGA GMP accreditation of Aegros’ production facilities is also good news for nations interested in creating their own fractionation facilities but are looking for a better, cheaper, faster, and more environmentally friendly solution that a Cohn fractionation facility.
Aegros’ TGA GMP accreditation assures interested nations that their own HaemaFrac® facility will form an important part of their health infrastructure, helping them to turn locally donated blood and blood plasma into PDMPs to meet their local needs, and building the self-sufficiency called for by the World Health Organisation.