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Materials Science and Engineering
Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications
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Characterizing Changes In Protein Quality Attributes To Assess Leachable Risks From Single-Use Bioprocess Containers, Nina Xiao, Colin Medley, Ian Shieh, Gregory Downing, Ankit Patel, Shelly Pizarro, Jun Liu
Characterizing Changes In Protein Quality Attributes To Assess Leachable Risks From Single-Use Bioprocess Containers, Nina Xiao, Colin Medley, Ian Shieh, Gregory Downing, Ankit Patel, Shelly Pizarro, Jun Liu
Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications
Leachables from bioprocess containers (BPCs) are a source of process-related impurities that have the potential to alter product quality and impact patient health. The leachables often exist at low concentrations that are difficult to detect and assess their impact on quality attributes (QA) of biotherapeutics stored in the BPCs. This study examines two monoclonal antibodies in a small-scale stressed model to detect and assess the presence of relevant BPC leachables by monitoring protein QA. The results from this study demonstrate that the stress model can inform a risk assessment of leachables on protein QA during routine manufacturing and assist in …