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Validation Items Validation Service
2015-01-14
Cells used to produce therapeutic proteins should have a precise nutritional balance to support their reproduction and growth. These nutrients are provided by culture media, which must be sterile. Final sterilizing filtration should assure the removal of bacteria and mycoplasma from culture media containing animal derived components.
Culture media are then stored in a fermentation vessel or bioreactor after bulk preparation and sterilizing filtration. Prefilters are used to remove most particulate and colloidal contaminants from culture media in order to extend the service life of final sterilizing filters.
Separation Goals
● Prefiltration
Remove colloids, lipids and particles
● Sterilizing filtration
Remove bacteria and mycoplasma
Application Requirements
● Prefiltration should remove particulate and colloidal contaminants effectively and not hinder the bypass of important components.
● Prefilters must have high flow rates and consistent high throughputs in order to finish the separating process timely and economically. Furthermore, the filtration system should be compatible with differences, resulting from batch to batch component variability.
Recommendation
Filtration Step | Recommendation |
Prefiltration | LPM, LPGF |
Sterile venting | LPTA |
Final filtration | LPS, LPSD |
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