WHO WE ARE

Aegros is Latin for ‘Patient’. We chose this as the name for our company  because it speaks to our focus on the patient. Every day we strive to place the patient 1st by providing therapeutic plasma products they would not otherwise be able to access.

At Aegros we believe, access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell, at Aegros, our mission is to put the Patients 1st through innovation.

Over 30 years we have developed the CyMES (Cylindrical Membrane ElectroSeparation) process which enables countries to turn human plasma they collect into life saving therapeutic plasma products. CyMES is a unique plasma fractionation process that helps countries become self- sufficient

OUR MISSION

Our mission is to develop and become the market leader in the emerging therapeutic plasma markets. The Company will achieve this by integrating the multi patent pending CyMES technology with existing processes to deliver safer & more affordable therapeutic plasma products.

OUR PEOPLE

Dr Nair graduated with honours in Physiology and Medicine from the University of Aberdeen and has a PhD in Medicine and Clinical Science from the Australian National University with specialty in cardiovascular medicine and haematology.

Dr Nair has received a number of awards from international organisations including being specially recognised for his role in coagulation research by the Australian Capital Territory government. He has run biotechnology companies in Australia, the US and Singapore. Dr Nair has been heavily involved in mergers and acquisitions especially in the US and Europe and has US financial experience. Dr Nair’s corporate experience includes financial raisings, corporate public relations and organisational integration strategies, Human Resources, IP strategy and management, financial management and Research and Development. Dr Nair is an international expert in Coagulation Science with a special emphasis on fibrinogen. Dr Nair is the author of over 100 research publications and has had over 50 patents on various aspects of electrophoretic plasma separation technologies, including the CyMES  and their applications in both plasma protein separations, renal dialysis and cellular separations. He discovered the use of nano carbon particles in the radiographic imaging of blood clots. Dr Nair is the principal inventor of the CyMES  having developed and patented the plasma protein fractionation applications in the late 1990s to early 2000s. Dr Nair together with Mr John Manusu also ran the then world’s largest independent plasma collection organization based in the United States. This business collected both normal and specialty plasmas, including hyperimmunes for the US Government bioterrorism program. Dr Nair has served on the boards of a number of international biotechnology companies and US state Commercialisation Boards for Georgia, Florida and Alabama.

Dr Nair and Mr Manusu recently received the first cGMP certification for a new plasma fractionation technology anywhere in the world for the last 40 years of the industry.

Mr Manusu has over 30 years experience running biotechnology companies worldwide. He has been involved in the development of the Aegros technology since its invention in 1985. Mr Manusu was also involved in the US plasma collection business creating, along with Dr Nair, the then world’s largest independent plasma collection organisation. This business collected both normal and specialty plasmas, including hyperimmunes for the US Government bioterrorism program. Throughout this period he has undertaken a number of significant cross border restructures, mergers, acquisitions and divestures. Finally, Mr Manusu has raised over $200 million in public funding and government R&D grants. Mr Manusu has a degree in Commerce and is a Fellow of the Financial Services Institute of Australasia. Mr Manusu has worked in the Australian, Asian and U.S. Biotechnology markets and is best described as a biotechnology entrepreneur.

Kailing Wang obtained her PhD in biochemistry at the University of Sydney in 1997, followed by post-doctoral training at the University of Sydney and the Victor Chang Cardiac Research Institute. She has over 25 years of medical research experience in the field of protein biochemistry, molecular biology, cell biology and virology. She worked for Gradipore/ Life Therapeutics from 2000 till 2006 and NuSep/ PrIME Biologics from 2011 to 2017 before joining Aegros. She has accumulated extensive hands-on R&D experience in membrane electrophoresis technology development, application development and viral/TSE clearance studies in plasma fractionation. At Sydney University Dr Wang was a Business Development Manager responsible for developing commercialisation opportunities across the research translation continuum. Dr Wang is the co-inventor of the CyMES and has authored a number of papers & patents with Dr Nair. Dr Wang was the Chief Scientific Officer in PrIME and was a significant contributor to establishing cGMP certification for the first time for a new plasma fractionation technology over the past 40 years.

Ms. Janet Bowen has almost 30 years of experience in the areas of sterile pharmaceuticals, biopharmaceuticals, oral solid dosages, and medical devices. During her career, she has held management positions in quality, regulatory, compliance, batch/lot release, and compliance/regulatory consulting. Ms. Bowen has worked for Sterling Drug, Sanofi, Abbott Laboratories, CAI Consulting, and PrIME Biologics prior to joining Aegros.  She hosted numerous successful inspections from the FDA, EMA, CMDA, TGA, Health Canada. While she was with Sterling Drug and Abbott, the sites received approval of 30 plus new products over five (5) year time span.  Many of them were generic drugs approved based on the data in the product dossier and without an onsite inspection.

She has prepared companies for many different agency inspections, setting up quality systems, and to prepare the associated submissions. Ms. Bowen is knowledgeable in the requirements of FDA, HSA, EMA, CFDA, PMDA, TGA, and Health Canada, as well as other agencies. During her time in the industry, she has successfully registered over 50 products with the US FDA, EMA, TGA, HSA, and Canada.

Ms. Bowen has a B.S. in Chemistry and a B. S. in Business Management. During her career, she has given presentations on Process Validation, Inspection Readiness, Combination Products, Quality by Design, and Aseptic Processing as well as others. She is a member of ISPE, PDA, ASQ, RAPS and is an active member of several regulatory Interest Groups within these organizations.

Ramachandran has over 21 years of experience within the Bio-pharmaceutical industry, specifically within manufacturing operations. He has worked both in Singapore and India and supported the APAC region. Rama has experience in API, Tablet, Liquid Oral, Sterile and Biologics Manufacturing.

Throughout the years, Rama has held roles of increasing responsibility within manufacturing operations including technology transfer, start-ups, EHS, quality, engineering, supply chain, environmental management, operational excellence and capital project management. His past work experiences include serving as the Managing Director for a manufacturing plant in India and as the APAC manufacturing operations leader.

Rama has worked for Smithkline Beecham, GSK, Pfizer, Zoetis and PrIME Biologics prior to joining Aegros. Rama holds a Masters in Business Administration from Strathclyde University, Scotland majoring in Strategy Management and a Bachelors Degree (Honours) in Chemical Engineering from the National University of Singapore.

At Aegros we believe it is important to honour our founding fathers. Aegros has two, Dr Joel Margolis and Dr Perry Manusu.

Perry Manusu was born on 23rd February 1929 and died on 20th June 2017. Perry along with Dr Joel Margolis were responsible for the establishment of Gradient Laboratories which evolved into Gradipore and ultimately Life Therapeutics.

As a society, we owe much to the rich and potent history that Joel and Perry created. Both men had many successful careers in their life, and yet both were driven by something more fundamental, a desire to do good. In Perry’s case electrophoretic separations was only one of his many achievements. They both represent the best of Australia: Immigrant background, Innovative, Dogged determination, and yet, willing to support those less fortunate than themselves.  For a brief history on Perry and his achievements click on the link https://onlinelibrary.wiley.com/doi/full/10.1111/avj.12737.

At Aegros we see Perry and Joel as symbolic of who we are and what we stand for: Inclusive, Innovative, Tenacious and Fairness.

We salute you Perry. Vale to a great Australian, and a man we would do well to emulate.

OUR HISTORY

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.

Dr Joel Margolis

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.

Dr Perry Manusu

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.

It is poetic that a Jewish man forced to leave Poland at the start of WWII should establish a company that would eventually lead to Aegros establishing the first commercial application of his dream in Israel. Dr Joel Margolis we salute you!