While we are all aware that donating blood saves lives, many aren’t aware that donating plasma is as critical as donating blood too. We hardly hear such thing out there. What is plasma? It is one of the major blood components, a straw-coloured liquid portion of the blood where all blood cells are suspended. It makes up about half (55%) of the total human blood nature. The protein-rich fraction of it is harnessed to manufacture life-saving therapies for individuals suffering from a variety of illnesses. As at 2015, 21.6 million litres of plasma are normally recovered each year. Within this, 4.2 million litres are transfused and 8.1 million are sent for fractionation.
In many low-income countries, there are fewer than 5 units of blood collected per 1,000 inhabitants annually and 10 units of blood per 1,000 inhabitants collected in the middle-income countries. On the other hand, in the high-income countries, there are 30 units of blood collected per 1,000 inhabitants. If a higher proportion of the blood collected in the low to medium income countries were separated into components, millions of additional plasma units would be generated. At the moment, it is not happening due to many technological and geographical related limitations, unlike in the more developed nations.
For the last 30 years, there has been a continual increase in the need for therapeutic plasma products, such as coagulation factors VIII and factor IX; human normal immunoglobulin G; anti-D, anti-tetanus and anti-rabies immunoglobulins which are on the World Health Organisation’s (WHO) list of essential medicines, at the global level. Human health, in general, are dependent on these. Most of the world’s plasma products supply is obtained by the fractionation of collected human plasma and these are collected in the United States or Europe, and a large proportion of the fractionated products is used mainly in the industrialised world. The situation leads to a substantial supply gap in many low to medium countries especially in Asia, South America and Africa.
With the rise in blood collections requirement to meet these therapeutic plasma demands, several countries within these continents are considering using the excess plasma obtained locally to prepare the fractionated plasma products. This fractionating initiative will help make the plasma products available in these countries.
The development requires an assistance of a set of new technologies. New technologies should be validated to make it compatible with the current process. It should be able to yield quality products, with a considerable output to meet the regional demand while able to comply with global quality and safety standards; and should be licensed.
A large-scale preparative electrophoresis technology across membranes of controlled porosity, previously known as ‘Gradiflow’, developed by PrIME Biologics in Singapore, was introduced as a means to provide a rapid, high-resolution purification of proteins from complex mixtures.
In the field of plasma proteins, it was initially applied to purify albumin, intravenous IgG, monoclonal antibodies, antibody fragments and fibrinogen. Proteins in the sample stream are then purified in a separated cartridge comprising a restriction membrane and separation membrane. After that, the right voltage is applied across the system to facilitate the movement of charged proteins. Proteins are then partitioned through a separation membrane system based on differences in sizes and charges at a given pH.
The benefits of this technology are obvious. The technique is claimed to have the capacity to separate proteins ranging in size from 10 to 1500 kDa, and it can also be used to remove or partition the unwanted contaminants, including viruses and prions. The process allows rapid purification of proteins and provides twice the yield of conventional separation techniques.
Xeraya Capital has taken a bold step by investing in emerging technologies, particularly in working with PrIME Biologics to explore the potential commercialisation of the blood plasma derivatives that caters to current regional demand. This initiative should help increase the awareness of the importance of it and its benefits. This initiative also resonates with the World Health Organization’s campaign to boost the usage of locally derived blood plasma rather than importing it. Thus, with the emergence of new technologies, low to medium capacity demand with twice the yield for blood plasma and derivatives at a lower CAPEX can be easily served especially in developing and less-developed regions.
