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Blood products refer to plasma protein products and corresponding recombinant protein products. Generally speaking, blood products consist of three categories，which are albumin, immunoglobulins, and coagulation factors. Blood products have been playing indispensable roles in the first-aid of critical illness, disease prevention and clinical therapeutics.
Due to the ever growing demand for blood products, the market has been under huge pressure for the expansion of purification capacity. Various purification methods have been involved in the purification of blood products, among which cold ethanol fractionation is regarded as the basic method of large scale plasma purification. However, as the separation technology innovates, chromatographic technology has witnessed a growing significance in the purification of plasma, among which ion exchange chromatography resin and affinity resin are most widely used in the particular sector.
Chromatography resin plays a vital role in the purification of blood products, ensuring the removal of impurities and isolation of target molecules with high purity and efficiency. In blood product purification, chromatography resin is utilized in various stages such as plasma fractionation, purification of clotting factors, and isolation of specific antibodies.
For instance, ion exchange chromatography resins are commonly used to separate proteins based on their charge properties, enabling the purification of specific clotting factors like Factor VIII and Factor IX from plasma.
Affinity chromatography resins, on the other hand, facilitate the isolation of monoclonal antibodies or other specific proteins from blood plasma or serum by exploiting their high affinity for target molecules.
Additionally, size exclusion chromatography resins are employed to separate blood components based on their molecular size, aiding in the purification of albumin or removal of aggregates from therapeutic proteins. Overall, chromatography resin technologies offer precise and efficient purification methods crucial for producing safe and high-quality blood-derived therapeutics used in various medical treatments.
When temperature is low, solubility of proteins can vary in ethanol of different concentrations. Different components can be obtained via change in concentration, temperature and pH value of ethanol. After centrifugating the precipitates, it is possible to repeat the above mentioned operation on the supernatant and precipitation.
Ion exchange chromatography functions via the different surface electric charges carried by different proteins. After performing desalting or cold ethanol fractionation on plasma, load treated plasma components and let it flow through the IEX resins, achieving desired purification purpose by binding and elution of proteins via solution condition alteration(eg.pH, salinity).
In affinity chromatography, protein separation is mainly achieved via specific adsorption among bio-molecules. Target protein can be purified by resins coupled with specific ligands(eg. Heparin,lysine and gelatin etc). Thus, for plasma proteins containing Fc-tag or antibodies, it is common to purify with Protein A affinity resins, which achieving both high purity and high yield.
This method achieves purification of proteins according to disparity of molecular weight of proteins. This method is usually applied in the desalting(first step) and polishing(last step) of chromatographic process, effectively removing HAV viruses.
Combining features of both fluidized bed chromatography and adsorption chromatography, flow the components in upflow at set flow rate in the column, where small molecules flow through before adjusting conditions including flow rate, pH and salinity to sequentially elute components with different molecular weights and charges. This is how the “first layered, then separated” effect is achieved.
Generally speaking, the application of chromatographic technology has fundamentally overcome the shortcomings of traditional blood products purification methods including cumbersome operation, time-consuming process, unsatisfying performance and low level of automation. Therefore,plasma usage efficiency and finished products quality will be dramatically improved, providing more blood products options for the market.
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