We trace our roots back to Dr Joel Margolis who escaped out of Poland as WWII was erupting in September 1939. Joel migrated to Australia with his family and read medicine at Melbourne University before becoming a preeminent researcher in the haematology field. Joel was the first person to develop a process to make FVIII AIDS free in early 1980’s.
Joel invented the tangential flow Electrophoresis process as an alternative to NASA’s attempts to do biological separations in space. Dr Perry Manusu, an Australian Veterinary, Surgeon and entrepreneur, who created the largest vet practice and vet pharmaceutical company, joined with Joel to develop this process which they called The Gradiflow. The first Gradiflow patent was lodged in 1984.
In 1985 John Manusu joined the company and helped take Gradipore public in May 1986.
Tangential flow Electrophoresis as applied to plasma protein purification was spearheaded by Dr Hari Nair when he joined Gradipore in 1998. He hired Dr Kailing Wang in 2000 and together they developed the various applications of the Gradiflow including viral and prion removal.
By early 2002 there were some 50 patent families covering a number of aspects of the Gradiflow technology. In 2004 the 3 founders (Perry, Hari, John) rebuilt Gradipore after a tumultuous board stoush. They then acquired Serologics, a US plasma collection business specialising in hyperimmune plasmas. These were all FDA approved collection centres. They used this acquisition to refine the plasma fractionation process, particularly for hyperimmune products. By 2007 the company, then called Life Therapeutics, was the largest non-fractionator plasma collection business in the world, collecting normal, hyperimmune and bioterrorism plasmas. They agreed to sell the business to the Italian fractionator Kedrion for US$150m. Having announced this agreement the founders retired. The replacement Board decided they could do a better deal and ultimately sold the collection centers for US$40m. This money was quickly spent on mining activities and the company was placed into receivership in 2012. This liquidation terminated the Gradiflow patents.
In the meantime, John and Hari setup another company called NuSep which developed an IVF application for the Gradiflow technology. A successful clinical study was completed in 2008. In 2010, NuSep was offered a small cGMP facility in Singapore and the company chose to reactivate the plasma separation technology. Hari and Kailing refined the fractionation process particularly around the disposable cartridge which enabled the processing of plasma from emerging countries.
In 2014 this business was spun out into a company called PrIME Biologics and was funded by private equity. On 1st July 2016 PrIME Biologics obtained cGMP registration from the Singapore Health Sciences Authority for the fractionation of Albumin from human plasma. This was the critical regulatory approval necessary to enable this process to be used to manufacture a therapeutic plasma product. This was also the first time in the last 40 odd years that a regulatory authority had granted GMP status to a company not using conventional Cohn/Chromatography for plasma fractionation.
Hari, John and Kailing left PrIME Biologics in April 2017 after it became clear funding of the commercial scale plasma fractionation facility could not be achieved within PrIME Biologics.
In May 2017 Hari, John and Kailing established Aegros. Hari invented the cylindrical electrophoresis system. Together with Kailing and a group of talented scientists they developed the CyMES process.
CyMES is a cylindrical electrophoretic instrument which offers at least 3 fold improvement on the Gradiflow. The architecture of CyMES fundamentally revolutionises plasma protein purification. This new cylindrical approach to plasma fractionation has produced 4 foundation patent applications with many more to come. The CyMES process manufactures human plasma protein with;
- High yield,
- Faster process time;
- Greater product safety; and
- High level of purity.
Further, CyMES is modular and kind to the environment. The process does not use ethanol nor other solvents and is capable of working with whole plasma and also Cohn fractions.
The evolution of electrophoretic separation has come from two generations of scientists and entrepreneurs. From the genius of Joel Margolis, the tenacity of Perry and John Manusu and the innovation of Hari Nair and Kailing Wang comes a whole new way of efficiently, ecologically and safely purifying human therapeutics.