PrIME Technology

The PrIME process offers the following advantages over the existing processes

Enhances the Finished Product Yield

The PrIME process consistently enhances 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 85% of the therapeutic product from the source plasma. This means the PrIME process produces significantly more end product compared to the existing process thereby increasing the supply of these lifesaving therapeutic products.

Ability to process Currently Underutilised Plasma (CUP)

The PrIME process can also process plasma that has not been collected under third world regulatory standards . This plasma is underutilised as it cannot be transferred across international borders. The PrIME process is a disposable batch process system eliminating the potential for contamination from one batch to the next. This enables the PrIME to process the Currently Underutilised Plasma, further increasing the supply of therapeutic plasma products from the limited plasma supply and potentially making emerging nations self-sufficient.

Greater Safety provided by the PrIME Process

The PrIME process is a membrane separation process in an electrical environment (Electrophoresis) and offers an additional and more efficient method to remove pathogens, viruses and other toxins from the source plasma. Based on independent studies 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 to the further safety of the end product of the manufacturing process.

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 per annum upwards.

Broader Range of Therapeutic Products

The PrIME process offers a high resolution and higher yield fractionation of plasma than the existing processes, thus contributing to a greater number of therapeutic products to be harvested from a given litre of plasma than the existing processes.

How it Works

PrIME stands for:

Preparative

Isolation by

Membrane

Electrophoresis.

The PrIME system separates proteins using a specially developed membrane using electrical current. Every biological component has a natural size and charge. Based on this information you can selectively move one biological component across the membrane away from any other biological contaminates. This is a very powerful separation process as it uses both the natural charge and size of the target molecule to make it transfer across the membrane away from the other components. Existing separation processes use the indiscriminate power of pressure to achieve a separation. Pressure is an indiscriminate force as it pushes all of the biological components through the membrane pores sacrificing selectivity and potentially safety and contributing to an overall process less efficient than PrIME. In effect pressure makes the membrane do all the separation work as opposed to the PrIME system in which the target protein is charged up and moves of its own accord across the membrane.

PrIME

Below is a picture of the 50L cartridge.

cartridge

PrIME’s disposable single use cartridge (see the picture) is designed to separate a molecule of a particular size. For example a 70,000 molecular weight cut off cartridge would be used to separate Albumin which has a molecular weight of 66.5 kda. With a 70,000 molecular weight cut off molecules larger than 70,000 will not transfer across the membrane allowing only smaller molecules to move across the membrane if they have the appropriate charge.

The PrIME cartridge is composed of special polyacrylamide membranes. These membranes are made up of pores with a torturous path rather than holes for the biological components to travel across the membrane. This path allows the system to selectively separate the molecules based on its size and charge and the speed at which these particles travel through the membrane.

In comparison, membranes used in current technologies such as nanofiltration have actual holes that allow passage of the proteins straight through the membrane. As such these membranes are manufactured with homogenous holes of a particular size allowing pressure to force particles through which would not otherwise normally cross the membranes. Pressure also causes fowling of membranes as it pushes all the components against the membrane ultimately blocking up the membrane pores. In comparison PrIME utilises a tangential flow of buffer over the membrane thus washing the membranes during separation and limiting if not completely obviating fowling.

Furthermore, the use of dual properties of size and charge allows the precise selection of the target molecules much more than the use of pressure for separation.


Research Reports and References to the PrIME Technology