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US 12,179,128 B2Granted
HPLC-based detection of flocculation agents in a protein sample
AssigneeUcb Biopharma Srl
InventorsAnnick Gervais, Joel Dubisy
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Abstract
The current application provides a rapid and simple method for measuring residual pDADMAC in a sample containing a recombinant protein of interest based on the combination of use of reversed-phase hydrophobic interaction HPLC and charged aerosol detection.
Claims11
A method for measuring poly (diallyldimethylammonium chloride) (pDADMAC) in a sample containing a recombinant protein of interest, the method comprising the following steps:
- a) applying the sample to a reversed-phase hydrophobic interaction HPLC column,
- b) eluting bound pDADMAC from the column using hydrophobic gradient elution,
- c) measuring pDADMAC recovered in step b) using a charged aerosol detector (CAD),
- wherein the sample applied in a) comprises 0.2-3% (v/v) of a CAD-compatible acid.
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