Modernizing clearance and quantification of host-cell proteins in mAb manufacture

To Improve reliability and quality assurance of the manufacturing processes through purification of monoclonal antibodies(mAbs) made by Chinese Hamster Ovary(CHO)
Categories
Process control
Active Immunization Countermeasures
Project status
88% Completed

Industry Need

  • Host-cell proteins (HCPs) are a major class of impurities in biopharmaceutical manufacturing. 
  • The removal of HCPs is complicated by the need to reduce both the total HCP content and the amounts of individual species that can be harmful to the product and/or patients.

Solution

Led by the University of Delaware, the team will develop new and complementary technologies for achieving and monitoring the removal of host-cell proteins (HCPs) in purification of monoclonal antibodies (mAbs) made by Chinese hamster ovary (CHO) cells.

Outputs/Deliverables

Coming soon

Impacts

This project will address the need to remove HCPs and to measure the amounts of individual HCPs in process streams. Once completed, the project will enable more robust processes in which HCP removal is achieved and monitored efficiently and in versatile process configurations.

This will be accomplished by improving HCP removal in multiple applications by employing novel LigaGuardTM materials that specifically capture CHO HCPs while allowing the mAb product to flow through unbound, characterizing HCP aggregates that contribute to HCP persistence in process streams and develop new methods to improve their removal, and benchmarking and standardizing liquid chromatography-mass spectrometry (LC-MS) technology to monitor HCP levels in biomanufacturing.

Publications

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Project Lead

University of Delaware

University of Delaware

Participating Organizations

Bristol-Myers Squibb

Bristol-Myers Squibb

Chromagenix

Chromagenix

Federal Stakeholder: National Institute of Standards and Technology

Federal Stakeholder: National Institute of Standards and Technology

Genentech, Inc.

Genentech, Inc.

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

North Carolina State University

North Carolina State University

Pfizer, Inc.

Pfizer, Inc.

Rensselaer Polytechnic Institute

Rensselaer Polytechnic Institute