Journal of Biotechnology & Biomaterials
Open Access

Abstract

As defined by US FDA, Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. PAT helps in building quality in the products, reduce failures, cut down overall cost and time, and can also be a substitute for expert human resource. Its significance is highly pronounced in the production of high value recombinant healthcare products that go for human consumption because of stringent regulations of FDA. In R & D and production facilities for biotechnology products, PAT requirements include real time measurement of key process variables such as pH, DO, substrate concentration, production concentration, cell growth, cell broth viscosity, off-gas composition, and concentration of harmful byproducts. In process analysis of typical physical and chemical parameters has been well established and is commonly used in lab scale, but not in production scale. Online measurement of key biological variables such as protein concentration is still a complex task at all scales. NIR, Raman Spectroscopy, fluorescence, dielectric based on-line, off-line and at-line systems in combination with expert system applications have filled the gaps to certain extent. Need for simple, robust, cheaper technologies for production facilities requires further research. A few case studies of Pichia pastoris, E. coli and Saccharomyces fermentations are presented to demonstrate the application of PAT for production of high value recombinant healthcare products.

Biography

Dr. Sreenivasula Reddy Ramireddy has completed his Ph.D. in Biochemical Engineering from University of Nebraska-Lincoln, USA. During and after his doctoral program, worked on more than 20 high value healthcare recombinant products in various bacterial and yeast expression systems. He participated in more than 500 fermentation processes in various scales mostly towards fermentation process development. He served more than 20 international clients including but not limited to US Armay/NIH/NIAID, Novartis, Proteon, Syngenta while working at BPDF, UNL and also as consultant. He founded two businesses one in USA and one in India, namely BioPATS and S4BIO. He developed one software product for control of bioreactor, BioPATS and a shake bioreactor. Several research and training projects/products are in progress. Earlier he worked as manager for fermentation development laboratory, BPDF, UNL, USA and also as guest faculty for bioprocess engineering and Technology at University of Hyderabad, India. His current clients include SRIBIOTECH, Hyderabad.