TABLE VI

Examples of Risk for Viral Clearance and Mitigation Strategy

RiskRisk Mitigation
Cell line with potential higher levels of RVLP or perceived higher likelihood of viral contamination (e.g., NS0)

  • - Additional VC steps (e.g., Protein A chromatography)

Molecule stability (e.g., aggregation at low pH used for VI)

  • - Detergent VI

  • - Excipient for protein stabilization

Molecule properties:

  • - Isoelectric point (may dictate less optimal AEX condition for viral clearance)

  • - Hydrophobicity (may impact virus filter fouling propensity)

  • - Additional VC steps (e.g., Protein A chromatography)

  • - Use alternative virus filter

Freeze thaw impact on virus filter fouling during small-scale VC validation studies

  • - Prefiltration for VRF feed to restore baseline flux profile