Plasma separation filtration


 

 

Human plasma contains many valuable therapeutic proteins, such as albumin, various immunoglobulins, factor VIII, fibrinogen, and other proteins. The process of extracting and purifying these proteins is called plasma fractionation. Plasma fractionation is achieved through a series of extractions and purifications of these proteins. Foreign substances in plasma can lead to product instability and downstream filter clogging. Therefore, pre-filters are necessary for classification and removal of impurities before chromatography and ultrafiltration. Terminal filters are used for sterile filtration of heat-sensitive proteins.

 

Separation Objective

● Prefiltration
Removal of colloids, aggregates, off-target proteins, lipids, and particulates prior to downstream purification to protect sterilization filters or chromatography columns.

● Sterile Filtration
Control microbial levels during manufacturing. Terminal sterile filling (refer to SVP)

 

Application Requirements


● Prefiltration must remove contaminants and must not retain the target product.
● To save time and cost, the filter must have a consistent high flow rate and high throughput.
● The filter should not contaminate the feed liquid, especially metals such as aluminum.

 

Recommendation

Filtration Steps

Recommendation

Prefiltration

MCE, GF, PP

Sterile Venting

PTFE

Terminal Filtration

PES

Eye drop filtration solution