Advances in Biopharmaceutical Technology in India
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Chapter 15:   Early-Stage Key R&D Components for Successful Development of Protein Therapeutics

Early-stage R&D activities are critical for the successful development of therapeutic proteins because careful attention to production hosts and the chemistry of the target protein can preemptively deal with issues that would complicate downstream processes. This highly multidisciplinary early-stage involves identification of production host(s), optimization of protein expression, identification of product attributes and modification of protein candidates through protein engineering and development of initial small scale bioprocessing methods. The development process during this early-stage product exploration might demand a multigenerational approach similar to the lead optimization process used in the discovery and development of small molecule drugs because protein behavior during expression and process development is difficult to predict. The Indian biopharmaceutical industry has well established expertise in the manufacture of vaccines and therefore, the development of the next generation variants of biogenerics would require the integration of protein engineering and bioprocess tools to address Indian market needs.

About the Author:

Krishna M. Madduri, Ph.D.
Senior Scientist, Discovery Research
Dow AgroSciences LLC
Indianapolis, IN 46268, USA

Krishna M. Madduri obtained a Ph.D. in Microbiology from Dalhousie University, Canada in 1990 and worked as a Postdoctoral Research Associate at the University of Wisconsin-Madison in the School of Pharmacy. For the past 12 years the author has been working in biotech and chemical industry in Discovery and Process Research areas. The author has extensive experience in several areas of microbial bioprocesses such as antibiotic biosynthesis, strain improvement, metabolic pathway engineering, biocatalysis and protein expression. The author spent the past 5 years in Discovery Research at Dow Agro- Sciences LLC, Indianapolis, USA focusing on various aspects of heterologous protein expression for biotech product development. The author has expertise in multiple protein expression systems, physiology and scale up and has special interest in the early-stage R&D activities that impact product development.

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Eric Langer
BioPlan Associates, Inc.
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