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Single-use modules for continuous removal of antibody fragments

Develop a single-use cartridge packed with a silica-based size-exclusion and mixed-mode (SEMM) adsorbent for capturing monoclonal antibody (mAb) fragments and residual host cell proteins (HCPs) from Protein A-eluates in flow-through mode
Categories
Proteins/ Antibodies
Project status
100% Completed

Solution

Performance Period: 1/1/2021 to 11/30/2022

This project presents the development of a single-use cartridge adsorbent for capturing monoclonal antibody (mAb) fragments and residual host cell proteins (HCPs) from Protein A-eluates in flow-through mode. The cartridge is packed with porous silica beads with optimal particle size and pore diameter, and functionalized with strong mixed-mode ligands. The pore diameter allows the access of mAb fragments and residual HCPs, while excluding the whole mAb molecules that flow through unbound. The species entering the pores are captured and retained by strong mixed-mode ligands, which are designed to capture a broad spectrum of impurities. The size of the silica beads enables high flow rates and low pressure drops. The combination of size-exclusion and mixed-mode (SEMM) mechanisms makes the SEMM-Silica a “platform” adsorbent, capable of operating on process fluids containing a broad range of mAb products and generated by different expression systems. Owing to the low cost of materials, the cartridge is disposable and the packed adsorbent recyclable and “green”. This technology complements our current LigaGuard adsorbent for the removal of HCPs from CHO cell culture fluids (NIIMBL 1.0-35), and supports the current effort to implement continuous operations in downstream bioprocessing, and reduce process footprint, costs, and time to market.

Outcomes and Impacts

Single-use cartridge for capturing antibody fragments and host cell proteins from Protein A elutes in flow-through mode

Optimize the mixed-mode ligands and the pore diameter of SEMM-silica beads to achieve efficient capture of the target species and high whole-mAb yield

Optimize particle size of silica beads and cartridge packing to enable fast flow, thus achieving fast processing with minimal pressure drops

Mixed-mode silica resins packed in cartridges for single-use applications, thus eliminating the need for cleaning and sanitization in place

Updates, Related Publications, and Deliverables

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Project Lead

North Carolina State University

North Carolina State University

Participating Organizations

LigaTrap Technologies, LLC.

LigaTrap Technologies, LLC.

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

MilliporeSigma/EMD Serono

MilliporeSigma/EMD Serono

Rensselaer Polytechnic Institute

Rensselaer Polytechnic Institute

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