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Technology

PrIME’s production process is based on the Preparative Isolation by Membrane Electrophoresis technology. The PrIME technology is a disposable, scalable manufacturing process through its modular  separation cartridge. The system can process any volume from 20L to 1,000,000L.

 

The PrIME process acts with the separation membrane in an electrical environment as opposed to being a pressure driven membrane based separation system. Using the natural charge found on proteins, the PrIME process enables the selective purification of the target molecules. The fact that all biological components in a nature also possess a net charge means that pathogens such as viruses and bacteria can also be selectively removed by the system.

 

The PrIME plasma process offers a number of advantages over the existing plasma fractionation processes. The existing processes are mostly built on the original Cohn fractionation process which dates back to WWII. The introduction of column chromatology late last century contributed to increased selectivity and the improved ability to reduce viral contamination. The current fractionation process, however, can be cumbersome and not modular and requires long periods of down time because of vigorous clean in place regimes to ensure safety in the system.


The PrIME process offers the following advantages over the existing processes: 

 

  1. Doubles the  Finished Product Yield

The PrIME process regularly doubles the yield of finished therapeutic plasma products relative to the existing processes. The existing processes at best recovers approximately 50% of the total therapeutic product from the source plasma. By comparison the PrIME process recovers over 90% of the therapeutic product from the plasma feedstock.  This means that the PrIME process can produce nearly twice the amount of end product compared to the existing process and therefore requires less plasma to produce the same amount.

  1. Ability to process Currently Unprocessable Plasma

The PrIME process can also process plasma that has not been collected in compliance with US FDA regulations. This plasma is normally discarded as it cannot be transferred across country borders. The PrIME process is based on a disposable batch process system that reduces the potential for contamination from one batch to the next. This enables the PrIME to process this Currently Unprocessable Plasma, further increasing the supply of therapeutic plasma products from the limited plasma supply.

  1. Greater Safety provided by the PrIME Process

The PrIME technology is an electrically driven membrane separation process (Electrophoresis) and offers an additional and more efficient method to remove pathogens, viruses and other toxins from the source plasma. The pathogen studies have demonstrated that the PrIME process offers an additional 4 log reduction of virus and significant log reduction of prions from plasma. Thus using the PrIME process contributes added safety to the end product of the manufacturing process.

  1. Lower Capital Cost

The existing fractionation processes are capital intensive. The smallest economically feasible fractionation process that can be built using the existing technology will cost approximately US$100m for a 100,000L facility. The PrIME process is modular and can be built to process from 10,000L upwards. A basic 50,000L facility will cost approximately US$20m. The therapeutic product that this 50,000L facility can produce is in excess of US$30m pa.

  1. Broader Range of Therapeutic Products

The PrIME process offers a selective and higher yielding fractionation of the plasma than the existing process. As a result, the PrIME process enables a higher yield and a greater number of therapeutic products to be produced from a given litre of plasma than the existing processes.