Enhancing mAb Platform Process using Membrane Chromatography (Affinity/Protein-A, Using Sartobind Rapid A) For FIH Molecules With Focus On Optimizing Cost And Accelerating Timelines

By Indraneel Sanyal , Nuresh Manukonda , Ankitha Hirematha and Mukesh Dakua , Buwadas R Raut , Madhav Naik

Membrane chromatography presents notable advantages over conventional column chromatography, including increased throughput, shorter processing times, and improved scalability. These benefits make it a promising tool for biologics production, particularly in accelerating process development and manufacturing timelines.

This study explores the implementation of Protein A membrane chromatography for monoclonal antibody (mAb) purification within a Contract Development and Manufacturing Organization (CDMO) setting focused on biologics development and the production of First-In-Human (FIH) molecules. To enhance efficiency, we transitioned our mAb purification platform from resin-based to membrane-based Protein A chromatography, assessing key performance metrics such as productivity, material costs, and facility utilization at scales of 50L, 500L, and 2000L.

Our findings highlight the potential advantages of this technology in clinical development, offering improved operational flexibility, reduced manufacturing footprints, and a more streamlined purification process.