Blood Products
Human plasma contains a large amount of therapeutically valuable proteins, such as albumin, various immunoglobulins, Factor VIII, fibrinogen, and other proteins. The process of extracting and purifying these proteins is known as plasma fractionation.
Plasma fractionation is achieved through a series of extraction and precipitation steps. Impurities in the plasma can cause instability of the product and blockage of downstream filters, so it is necessary to use prefilters to remove them. Before chromatography and ultrafiltration, the solution also needs to be clarified and impurities removed. For sterilizing heat-sensitive proteins, final sterile filtration is usually used.
Purpose of Separation
● Prefiltration
Before downstream purification, remove colloids, aggregates, non-target proteins, lipids, and particles to protect downstream sterile filters or chromatography columns.
● Sterile Filtration
Control the level of microorganisms during the production process.
Final Sterile Filling (refer to the section on small-volume injections)
Application Requirements
● The prefilter must be able to remove impurities without retaining the target product.
● To ensure production time and cost, the filter should have a stable high flow rate and high throughput.
● The filter must not contaminate the feed solution, especially with metals such as aluminum.
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