By product typeBy application
Validation Items Validation Service
2013-11-03
Mammalian cells are cultured by various methods for the production of therapeutic and diagnostic proteins in different scales. These cells are grown in a bioreactor or fermentation vessel.
The first step of purification is to remove cells, debris and particles prior to the next step. TFF or NFF could be used in the first step. Whether to use TFF or NFF depends on batch sizes and frequencies of feeding. If the batch feeding is small or in a low frequency, NFF is much better for its cost economics. In other cases, TFF is more suitable.
Separation Goals
Clarification/Prefiltration
(Step One and Step Two)
Remove cells, cell debris and particles effectively and economically
Final Filtration
Reduce bioburden or remove bacteria prior to further purification steps
Application Requirements
One-step filtration is not enough to remove all the particles for their great number and ranges. It’s more cost-effective to use two or three steps filtration in most circumstances.
Recommendation
Filtration Step | Recommendation |
Prefiltration | LPGF, LPPF |
Fine filtration | LPGF |
Final filtration | LPS, LPSD |
Sterile venting | LPTA |
Last Case: LVP
Next Case: No information!