DEVELOPMENT OF NOVEL BIOPHARMACEUTICALS: CHEMICAL ENGINEERING APPROACHES IN PROTEIN DRUG PRODUCTION AND DESIGN

Abstract

Biopharmaceuticals have revolutionized contemporary medicine, where particular treatments for several diseases, such as cancer, autoimmune diseases, and genetic diseases, are attainable. Manufacturing of biopharmaceuticals is discussed here with emphasis on host expression systems, bioreactor technology, and purification steps. The study highlights the significance of mammalian cell lines, for example, CHO cells, in realizing high-yielding protein production and perfusion bioreactors' role in reducing production time.Also, advancements in downstream processing like multi-column chromatography and nanoparticle drug delivery have played a crucial role in enhancing formulation stability and therapeutic effectiveness. Despite these, most challenges such as glycosylation variability, high production costs, and stringent regulatory requirements persist in large-scale biopharmaceutical production. The discussion calls for the significance of process analytical technologies (PAT) and continuous manufacturing strategies in ensuring product uniformity and keeping production costs to a minimum. Besides, single-use bioreactor advancements and excipient optimization have extended drug shelf life and improved protein stability. Future studies must aim at host cell engineering extension, purification technique enhancement, and incorporation of advanced formulation strategies to enhance biopharmaceutical access and affordability. The results of this study highlight the importance of ongoing collaboration among industry, regulatory agencies, and scientists to enhance innovation and optimize biopharmaceutical development.