This commentary outlines a proposed approach for navigating remediation (non-routine sanitization) of contaminated affinity-based resins. The methodology for collection of relevant information and for subsequent decision-making is presented, along with a tool for determining risk to the process associated with proposed return-to-use of remediated resin.
Keywords: Affinity resin; Bioburden; Biofilm; Chromatography; Contamination; Protein A; RBIA; Risk-based impact assessment.
© PDA, Inc. 2023.