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Validation Items Validation Service
2013-11-03
Human plasma contains lots of valuable therapeutic proteins, such as albumin, a variety of immunoglobulins, VⅢ factors, fibrous proteins and other proteins. The process of extracting and purifying these proteins is called plasma fractionation. Plasma fractionation is accomplished by a series of extracting and purifying such proteins.
Foreigners in plasma can result in instability of products and clogging of downstream filters. Therefore, prefilters are necessary for classification and removing impurities prior to chromatography and ultrafiltration. Final filters are used for the sterilizing filtration of heat-sensitive proteins.
Separation Goal
●Prefiltration
Remove colloids, aggregates, non-targeted proteins, lipids and particles to protect sterilizing filters or chromatography column prior to downstream purification.
● Sterilizing filtration
Control the microorganisms level during the manufacturing process.
Final sterile filling (referred to SVPs)
Application Requirements
● Prefiltration must remove contaminants and have no retention of target products.
● Filters must have consistent high flow rates and high throughputs for the sake of time and cost.
● Filters should not contaminate feeding liquids, especially metals such as aluminum.
Recommendation
Filtration Step | Recommendation |
Prefiltration | LPM, LPGF, LPPF |
Sterile venting | LPTA |
Final filtration | LPS |
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