DBT COE for biopharmaceutical Technology
CBT was established in 2015 at IITDelhi with funding from the Department of Biotechnology, Government of India. This was to recognize the role of biotechnology towards producing affordable biotherapeutics. CBT works in collaboration with academia, industry, regulatory and government stakeholders to research, develop and train in best practices in biopharmaceutical manufacturing.
Manufacturing of biotherapeutic products is a key component of the “Make in India” campaign. Continuous processing promises a 10-15 X increase in productivity and a 50-75% reduction in cost of manufacturing of biotherapeutics. CBT already has ready-for-licensing continuous platforms for production in both microbial and mammalian platforms. We are currently engaged in licensing these platforms to the biopharma industry.
Analytical & functional characterization of biosimilars
CBT has the required infrastructure, expertise, and experience to perform detailed analytical and functional characterization of biosimilars. We have already published exhaustive comparability exercises of Filgrastim , Rituximab and Trastuzumab biosimilars that exist in Indian markets. We have recently patented FTIR based fingerprinting to eliminate counterfeiting of biotherapeutics
Affordability and accessibility of biotherapeutics continues to be a concern for Indians and most of the world. One of the focus areas for CBT is to identify and study factors that drive pricing of a biotherapeutic product and thereby create strategies for making these products affordable. We think this information would be of great interest to the policymakers as well as those engaged in the National List of Essential Medicines (NLEM) Committee.
CBT is harnessing the power of Artificial Intelligence and Machine Learning for healthcare applications. Ongoing projects include Early detection of pancreatic cancer from MRI using deep learning, Acute decompensated heart failure prediction using AI/ML, Medical image analysis using deep learning, and Multivariate data analysis using AI/ML. We think that apps driven by such AI/ ML models would be commonly used by the physicians in the near future.
Automation and digitization of biopharmaceutical processing is a key mandate for CBT. Together with our industry partners we are working towards development of a control system network architecture using distributed control system that enables real time process monitoring and control. Mechanistic models of the unit operations, digitization of the process and analytical data, real time process monitoring, and model based control are the required elements.
Research on COVID-19
COVID-19 has shook the world. CBT has multiple projects in this space including diagnostics, vaccines, biotherapeutics as well as epidemiological studies of the COVID 19 data. In addition we are exploring the possibility of applying our continuous processing platforms for enhancing the productivity of the much needed COVID-19 vaccines to make them more affordable and meet the demand.