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Integrated Chromatographic Platform for Simultaneous Separation of Charge Variants and Aggregates from Monoclonal Antibody Therapeutic Products
Author(s) -
Kateja Nikhil,
Kumar Devashish,
Godara Avinash,
Kumar Vijesh,
Rathore Anurag S.
Publication year - 2017
Publication title -
biotechnology journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.144
H-Index - 84
eISSN - 1860-7314
pISSN - 1860-6768
DOI - 10.1002/biot.201700133
Subject(s) - biopharmaceutical , monoclonal antibody , biosimilar , innovator , quality by design , chromatography , chemistry , critical quality attributes , process (computing) , comparability , computer science , antibody , mathematics , microbiology and biotechnology , biology , combinatorics , intellectual property , particle size , immunology , operating system
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.