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. 2023 Sep-Oct;77(5):420-435.
doi: 10.5731/pdajpst.2022.012814. Epub 2023 Jul 14.

A Risk-Based Approach for Managing Affinity Resin Contaminations

Beth Fulton  1 , Angelica Welch  2
Affiliations

A Risk-Based Approach for Managing Affinity Resin Contaminations

Beth Fulton et al. PDA J Pharm Sci Technol. 2023 Sep-Oct.

Abstract

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.

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