Content:
Fot the Process Characterization of sterile filtration of Mabs,
we found out that at the beginning of the sterile filtration of Drug substance, there will be a small portion of protein and PS20/PS80 hold by the filter membrane and after the membrance is saturated, the protein PS20/PS80 concentration of output flow will be stable.However, the relation between the flow speed and retention effect haven't been defined. Should we concern about that？
Moreover，what is the good strategy to reduce the risk of reduced protein concentration and PS20/PS80 content? Dump the first portion of outflow, or Dilute this effect by transferring the outflow of filtration into a transit bag to a cetain amount of volume（need to Be defined by PC） before Fill to ensure the product quality consistency?
Does anyone have any expereience of that?
Can someone share some related articles or guidance?
Thank you!
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