Chandigarh,Nov. 23, 2017-The Institute of Microbial Technology (IMTECH), Chandigarh celebrated CSIR’s Foundation Day today by organizing several events, the most important among those being a Foundation Day Lectures by:  

Prof. Anurag S. Rathore (Keynote address), Department of Chemical Engineering, Indian Institute of Technology, New Delhi

Prof. Pramod P. Wangikar (Guest Talk), Department of Chemical Engineering Indian Institute of Technology, Mumbai

Mr. Andrew Ayre (Special Address), British Deputy High Commissioner, Chandigarh

Prof. Anurag S. Rathore, in his Foundation Day Lecture at IMTECH said that the Biosimilars or follow-on protein products refer to “follow-on” versions of other licensed protein products that are already on the market. The talk addressed three topics. First, the economic drivers for the biosimilars were discussed and the unique requirements of the emerging markets were highlighted. Next, the challenges that are faced during commercialization of biosimilars were presented. While the central issue that has and will continue to dominate is our limited understanding of how the different quality attributes of a protein product impact its safety and efficacy, progress has been made via development of new tools that elucidate this relationship. Gaps that current exist  include a lack of standardization in which process and clinical data is collected, analyzed and reported; accessibility of data across molecules and sponsors; complexity of protein products with respect to the numerous quality attributes, structural heterogeneities and molecule to molecule differences in behavior; limitations associated with the ability of non-clinical tools in predicting clinical safety and efficacy; and complexity of the processes that are used to manufacture these protein products along with the raw materials that they use. Finally, technology drivers that can alleviate the above mentioned gaps were discussed. They include high throughput process development (HTPD), computational fluid dynamics (CFD), multivariate data analysis (MVDA), quality by design (QbD), and process analytical technology (PAT).