Generation of a batch pre-clinical material can be a cost prohibitive step for drug innovators due to the high cost of goods associated with the manufacture of biologics. For monoclonal antibodies, the cost associated with chromatography resin procurement can make up a significant portion of the total manufacturing cost of the batch. Multi-column continuous chromatography offers a strategic solution to this challenge by dramatically reducing the required resin volume to perform a given chromatographic purification. However, since manufacture using continuous chromatography involves new challenges related to the added process complexity, few contract development and manufacturing organizations (CDMOs) offer access to this technology despite its cost saving potential. Our work is focused on simple and straightforward methods for CDMOs to incorporate continuous chromatography strategies during pre-clinical and clinical drug production. As part of this work, we have converted Protein A capture steps for 2 monoclonal antibodies from batch to multi-column continuous mode using the Cadence BioSMB<sup>TM</sup>, producing eluate streams with comparable product quality and impurity levels. The continuous process was then executed at the pilot scale as part of a project deliverable to produce high purity product to supply pre-clinical studies. This proof-of-concept study shows the important potential for continuous technology to drive down cost of goods, particularly during the early phases of a drug development program. This study also demonstrates the role that contract manufacturers can play by offering continuous manufacturing as an enabling technology for future cost savings and bringing new drugs to the market at reduced cost.

Multi-column continuous chromatography as a strategy for reducing cost of drug development

255th National Meeting (2018)

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