History

The History of the Development of the PrIME Technology

1984

Where it all started – Gradient Labs Circ 1984

Where it all started – Gradient Labs Circ 1984

Dr Joel Margolis invented the original PrIME unit in 1984. Dr Margolis invented the PrIME Technology when he learnt that NASA was attempting biological separations in space. He reasoned that an innovative approach to technology that worked in earth’s gravitational field was a pre-requisite for a bioseparation technology to work in space. Dr Margolis was a world renowned scientist in the field of Haematology. Dr Margolis’ achievements includes involvement in the discovery of the blood clotting Factor XII and the ground breaking research to manufacture therapeutic FVIII AIDS free. His production method was adopted by CSL, who sold their FVIII until the early 2000s as the ‘Margolis FVIII’. In the late 70’s Joel teamed up with Dr Perry Manusu to set up Gradipore. Perry had been a very successful Veterinary Surgeon creating the largest Veterinary practice in Sydney and establishing a Veterinary pharmaceutical company called Troy Laboratories. Dr Manusu, together with his son, John Manusu, then set up Gradipore, took it public in 1986 raising the seed funds to develop the PrIME Technology.

1984 - 1997

Perry and  John Manusu set up Gradipore in 1985, took it public in 1986 raising the seed funds to develop the PrIME Technology. During the period 1984 to 1998 the PrIME Technology was developed by Dr Margolis and Dr Perry Manusu. They created a number of improved units, developed the initial membranes and separation protocols. In 1995 Dr Margolis retired. Also during this period, initial work was undertaken by Prof David Solomon of The Melbourne University, School of Chemistry to produce a continuous membrane manufacturing process. Prof Solomon is best known as the recipient of the Australian Bicentennial Science award for developing Australia’s plastic currency which has been adopted by a number of counties. The initial separations undertaken by Drs Margolis and Manusu were done using a number of different raw materials including human plasma, eggs and wheat.

1998 -2003

In 1998 Dr Hari Nair joined Gradipore to head up the development of the PrIME process. Given Dr Nair’s background in the Fibrinogen area, he focused the research on separation of human plasma, and specifically the replication and scale up of the existing fractionation processes using PrIME. By 2000, separation protocols had been established for human Albumin, IVIG and a number of other plasma proteins. At this stage Dr Perry Manusu retired from the Board, but maintained an ongoing involvement in the R&D area. Dr Nair organised for work to show the PrIME process could remove viruses, bacteria, endotoxins and prions from the source material including plasma proteins. The prion removal work was undertaken in association with the Scottish National Blood Transfusion Service and QOne Biotech (Now owned by BioReliance) in 2002. Throughout the period 1999 to 2003 a number of demonstrations of the PrIME Technology were undertaken with the large fractionators. While these separations were successful there was always the question of how to incorporate this technology into their fractionation process, particularly given the millions of liters processed by the larger fractionators. As such the process was not adopted by the large fractionators. Ultimately the fractionators decided not to adopt the PrIME Technology as it would take 5 years to gain regulatory approval and cost in excess of $50m.
Researcher with the first commercial embodiment of the PrIME Technology – BF-400 Circ 1998

Researcher with the first commercial embodiment of the PrIME Technology – BF-400 Circ 1998

2003 - 2013

Between 2003 and 2009 the focus was on creating the largest independent plasma collection business. This business was ultimately sold to several fractionators at which time the focus returned to developing the PrIME Technology. In 2009 a new opportunity arose to process small volumes of plasma associated with the creation of a SARS hyperimmune. Dr Hari Nair and John Manusu approached the Singapore Government to see if the PrIME Technology could help address this issue. Over the next 3 years Dr Nair developed a disposable version of the PrIME Technology which could process small volumes. By making the process disposable it also enabled the PrIME Technology to process the plasma that is currently underutilised in many countries. This plasma, which we call Currently Underutilised Plasma (CUP), if processed could be used to save many lives. In July 2011 PrIME Biologics was awarded a soft loan from the Singapore Government EDB. This Government support was an important factor which helped PrIME Biologics acquired a state of the art manufacturing facility in Singapore. With the purchase of this facility PrIME Biologics was able to raise the required funds to set up a current Good Manufacturing Practice (cGMP) facility and bring the first therapeutic product manufactured using the PrIME Technology to market.