Integrated Chromatographic Platform for Simultaneous Separation of Charge Variants and Aggregates from Monoclonal Antibody Therapeutic Products. Issue 11 (9th October 2017)

• Record Type: Journal Article
• Authors: Kateja, Nikhil; Kumar, Devashish; Godara, Avinash; Kumar, Vijesh; Rathore, Anurag S.
• Is Part Of: Biotechnology journal. Volume 12:Issue 11(2017)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2017-10-09
• Subjects: aggregates -- biosimilars -- charge variants -- integrated chromatographic platform -- monoclonal antibody purification; Biotechnology -- Periodicals; 660.605
• DOI: 10.1002/biot.201700133
• Languages: English
• ISSNs: 1860-6768

Abstract

Abstract : Achieving consistent product quality of a biotherapeutic is a major target for any biopharmaceutical manufacturer, even more for a biosimilar producer as comparability with the innovator product is a regulatory expectation. The complexity of biotherapeutic products and their tedious manufacturing processes, however, make this a non‐trivial exercise. The primary motivation of this work is to develop an integrated chromatographic platform for purification of monoclonal antibody (mAb) therapeutics that can deliver the desired separation of both charge variants and aggregates, in addition to the process related impurities like host cell proteins (HCP) and host cell DNA. To achieve the same, an integrated two‐stage chromatographic process platform consisting of cation exchange chromatography and multimodal chromatography is being proposed. The versatility of the proposed platform has been successfully demonstrated for three different mAbs. It have been shown that in each case charge variant separation is achieved with the required clearance of aggregates (<1%), HCP (<10 ppm), and DNA (<5 ppb). Moreover, the proposed platform is conducive to use for development of a continuous process and offers smaller process time, lower buffer utilization, and decreased operational costs when compared to the conventional purification platforms. Abstract : An integrated two‐stage chromatographic platform process consisting of cation exchange chromatography and multimodal chromatography is being reported to achieve simultaneous separation of charge species and aggregates post Protein A capture of mAb therapeutics. This platform can be a vital tool for a producer of biosimilar product as comparability with the innovator product is a regulatory expectation. Moreover, the proposed platform is conducive to use for development of a continuous process. This article is part of an AFOB (Asian Federation of Biotechnology) Special issue. To learn more about the AFOB, visitwww.afob.org .