Abstract
Over the past decade, immunotherapy has tremendously augmented the traditional treatment strategies in cancer cure. It has provided newer opportunities to research and development of enormous varieties of lifesaving drugs—each representing its strengths and weaknesses. None-the-less, it has improved treatment protocols, provided simple solutions to complex biological problems, and increased the overall disease-free survival within patients. However, the beneficiaries of these technological advancements are very few. This may be due to the heterogeneity within individuals (which is generally not considered for development of Immunotherapeutics) or due to the fact that it is high risk, high investment, and high returns technology, supplemented with side effects. Some of these manageable factors like cost can be worked upon by newer strategies or improvising existing manufacturing processes—to scale up within regulatory compliances. Process scale up is an integral step in large scale manufacturing that demands for critical understanding of process attribute, analytical tool, and product quality. Designing of scalable technology and manufacturing machineries with emphasis on process invariability, minimized time, and cost of therapy will provide the success of any immunotherapeutic drug. This chapter is an attempt to provide a bird’s eye view on the various opportunities available in the drug designing, scale up and analytics of immunotherapeutic drugs.
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Palahe, P., Pardhi, V. (2021). Discovery, Screening Methods, Design Considerations, and Scale-up Aspects of Immunotherapeutic Drugs. In: Sawarkar, S.P., Nikam, V.S., Syed, S. (eds) Immunotherapy – A Novel Facet of Modern Therapeutics. Springer, Singapore. https://doi.org/10.1007/978-981-15-9038-2_8
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