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        Bioprocess Challenges in Purification of Therapeutic Protein Charge Variants

        Tarun Gupta,Anuj Kumar,Sriram Seshadri 한국생물공학회 2023 Biotechnology and Bioprocess Engineering Vol.28 No.4

        Biopharmaceuticals are complex therapeutic protein molecules produced in living cells and have been a major driving force for drug development in the pharmaceutical sector in recent years. Monoclonal antibodies (mAbs) are biological macromolecules used for treating life-threatening and rare illnesses. mAbs with post-translation alterations can be observed during the assessment of charge variants. Controlling the charge variant profile of therapeutic protein is a regulatory requirement to confirm that the macromolecule complies with the quality parameters to ensure patient safety. Unfortunately, manufacturing these biopharmaceuticals is very expensive. However, the emergence of biosimilars has reduced developmental cost across the biopharmaceutical industry. The advent of biosimilars has constrained the development of more efficient downstream bioprocesses that are mainly considered the bottleneck of the manufacturing process. This review focuses on the existing methods for charge variants separation and process optimization and indicates new approaches for future developments. It also provides a comprehensive summary for the biological community about the impact of charge variants.

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        Understanding the Role of Heat Shock Protein Isoforms in Male Fertility, Aging and Apoptosis

        Kaveri Purandhar,Prasant Kumar Jena,Bhumika Prajapati,Parth Rajput,Sriram Seshadri 대한남성과학회 2014 The World Journal of Men's Health Vol.32 No.3

        Heat shock proteins (HSPs) play a role in the homeostasis, apoptosis regulation and the maintenance of the various other physiological processes. Aging is accompanied by a decrease in the resistance to environmental stress, while mitochondria are primary targets in the process of aging, their expression decreasing with age. Mitochondrion also plays a significant role in the process of spermatogenesis. HSPs have been shown to be involved in apoptosis with some of acting as apoptotic inhibitors and are involved in cytoprotection. In this review we discuss the roles of Hsp 27, 60, 70, and 90 in aging and male infertility and have concluded that these particular HSPs can be used as a molecular markers for mitochondrially- mediated apoptosis, aging and male infertility.

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