Efficiency of ultrafiltration/diafiltration in removing organic and elemental process equipment related leachables from biological therapeutics
Bin Sun,
Mahsa Hadidi,
Jose Santiago Nuñez
et al.
Abstract:In the production of biological therapeutics such as monoclonal antibodies (mAbs), ultrafiltration and diafiltration (UF/DF) are widely regarded as effective downstream processing steps capable of removing process equipment related leachables (PERLs) introduced upstream of the UF/DF step. However, clearance data available in the literature are limited to species with low partition coefficients (log P) such as buffer ions, hydrophilic organic compounds, and some metal ions. Additional data for a wide range of P… Show more
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