Decision Support System for Biotech Processes
Vishwanath Hebbi (Prof. Anurag Rathore)
08th November 2017, Wednesday, 04:30‐05:00 pm (25+5 mins), ChE Seminar hall
Biotech industry is growing very fast with new approvals coming every year. With the advent of Biosimilars in different parts of the world, market has become quite competitive. Some of the therapeutics have more demand supply gap owing to increase in manufacturing capacity of the plant. Over all there is huge drive in recent years, from academia and industries towards creating platforms for very large scale therapeutic drug production. There are various reports that discuss on continuous processing of Monoclonal antibodies, E coli. Based drugs. Appropriate monitoring tools and control strategies have been a part of manufacturing process in industry, but majority of them are used as offline tools. But current urge is to have real time analytical tools through which one can control the critical quality attributes (CQAs) maintaining the Critical process parameters at acceptable rang. This is one of the important area of active research in biopharmaceuticals.
As for as process consistency and product quality is considered, the manufacturing process has to be monitored and controlled at the critical steps. This is quite necessary at larger scale and for continuous process. Online monitoring and control tools are required to take quick decisions. Majority of reports in this area are on pharmaceutical, petrochemical, food industries. Reports on monitoring and controls in biopharmaceutical area are concentrated mainly on fermentation and cell culture with few on downstream processing. Downstream process clears mainly process related and product related impurities. Current work will be on identifying CQAs, identifying critical unit operations that affect Particular CQAs, developing monitoring tool for real time analysis of CQAs and finally to develop a control strategy to control the CQA in the process.
The first part of the research work comprises of developing reference method for measuring different excipients which are used in formulation of biotech products. Further, drift of excipients during final ultrafiltration/diafiltration (UF/DF) has been modeled to predict their levels in the final product. The second part of the work consists of developing a process for purification of a recombinant peptide and identifying the critical step which affects the process.