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An Innovative Approach to High Aggregate Challenges in Engineered Monoclonal Antibodies Using Flow Through Chromatography

BPI Contributor

March 25, 2024

15 Min View

Date: Mar 21, 2024

Duration: 15 Min

This webcast features: Al De Leon, PhD, Manager, Research and Development, Thermo Fisher Scientific.

Advances in design of engineered monoclonal antibody (MAb)–based therapeutics are generating a wide range of novel, efficacious biomolecules. However, their manufacturing can also form mispaired products, fragments, and high levels of aggregation, resulting in downstream purification polishing challenges for traditional processes that result in low recoveries and poor process economics.

In this webinar, hear from a Thermo Fisher technical specialist on addressing the challenges with antibody aggregates and process related impurity removal using a new high performance chromatography resin specifically developed to address removal of high molecular weight species in flow-through mode by immobilizing a flocculant onto a rigid porous bead.

Key Takeaways:

  • Tackle challenges and limitation of traditional polishing steps to address high aggregate engineered MAb feedstocks.

  • Analyze performance data on aggregate removal, impurity reduction (including MS/MS2 HCP analysis) and process efficiency gains when using a novel chromatography resin based on caprylic acid bound to a rigid POROS™ backbone.

  • Understand how Thermo Scientific™ POROS™ Caprylate Mixed-Mode Cation Exchange Chromatography Resin can be used in flow through mode to expand the normal operating range for aggregate removal polishing steps.

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