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.
Upstream Processing
At the forefront of bioprocess innovation, the CBT delivers advanced solutions for biopharmaceutical manufacturing. The Centre’s expertise focuses on critical upstream technologies, including high-yield strain and cell line development, cost-effective media optimization, and robust bioreactor control through Process Analytical Technologies (PAT) methodologies. CBT addresses complex manufacturing bottlenecks to ensure processes are both scalable and commercially viable. We are involved in collaborative projects in the areas of process development, process optimization and advanced bioreactor control for production of a range of biotherapeutics, including virus-like particles (VLPs), mAbs, nanobodies, and insulin analogues.
Analytical & Functional Characterization of Biosimilars
CBT has the required infrastructure, expertise, and experience to perform detailed analytical and functional characterization of biosimilars. We have contributed towards creation of novel and advanced methodologies for characterization of biotherapeutic products as well as establishing structure-function relationships. Lately we have focused on creating novel spectroscopic methods for measuring CQAs as efficient alternatives to the traditional LC and MS approach. We have extensively published on multi-attribute monitoring (MAM) approaches to make bioanalytical applications efficient. Another topic of interest is integrating advanced data analytics (machine learning) for enhancing the information that typical analytical tools generate. We have successfully demonstrated use of this approach for characterizing size heterogeneity (from DLS data), glycans (from FLD and FTIR) and several other applications. In addition, we are also targeting novel formulations for the range of biotherapeutic products that we are working with.
Pharmacoeconomics
At CBT, we understand that novel and breakthrough therapies like mAbs mean nothing if patients cannot access them, specifically true for Low- and Middle-Income Countries (LMICs) like India. Based on this understanding, we have developed an in-house economic model using advanced process economics modelling tools to evaluate the commercial viability of different manufacturing approaches for mAbs and other emerging therapies, identifying economic hotspots and areas for improvement. We believe this will help decision makers, manufacturers and other healthcare stakeholders, by directly addressing one of the main barriers to making these critical treatments more widely available.
Downstream Processing
CBT delivers advanced biopharmaceutical manufacturing solutions. The downstream processing group's focus is on developing purification platforms for various proteins and peptides with maximum yield and productivity. The infrastructure here at CBT supports in achieving this aim for microbial as well as mammalian products. With multiple unit operations experience, we have expertise in refolding, chromatography, virus inactivation, and filtration; we have developed purification platforms for a range of biotherapeutic modalities including mAbs, peptides, nanobodies, VLPs and ADCs. We have also successfully created novel PAT based schemes for delivering real time monitoring and control of bioprocesses.
Continuous Processing
We have a state-of-the-art facility at CBT for continuous manufacturing of microbial and mammalian biotherapeutic drugs. We have created continuous platforms for both product classes and demonstrated how continuous processing can deliver consistent product quality. These platforms involve use of digital twins, real time process monitoring using PAT, and real time process control. We have observed that implementation of these platforms can deliver 10–15X higher productivity and 50–75% reduction in Cost of Goods.
Process Control
CBT specializes in integrating artificial intelligence, machine learning algorithms, and Process Analytical Technology (PAT) to create holistic control systems that can predict, prevent, and respond to process variations in real-time. Our continuous bioprocessing platforms utilize deep neural networks for rapid control responses, multivariate data analysis for quality prediction, and model predictive control for autonomous decision-making.
Data Analytics
We have harnessed cutting-edge AI, deep learning, and large language models (LLMs) to accelerate innovation and build the foundational tools for next-generation applications. Our work focuses on enhancing advanced process control, developing real-time enablers for continuous manufacturing of biotherapeutic products, and enabling intelligent clinical decision support. Applications include creating digital twins of complex systems—ranging from manufacturing units to biological processes—and mapping pathways with sophisticated machine learning, mathematical, and hybrid models. Automation of workflow to make analysis of data from mass spectroscopy, FTIR, NIR, and Raman has been demonstrated to yield significant efficiencies. With strong expertise in medical image analysis and multimodal large language models, we support hospitals and healthcare providers in tasks such as radiology image interpretation and integration of imaging data with patient records. Our AI solutions are designed to provide explainable, reliable, and secure insights, enabling clinicians and biomanufacturers alike to improve decision-making, optimize processes, and deliver better outcomes.
New Age Therapeutics
CBT extends beyond traditional mAbs to be a forerunner on next generation biotherapeutic modalities. Our pipeline includes Antibody Drug Conjugates (ADCs) for targeted payload delivery, microbial and mammalian Virus-Like Particles (VLPs) for vaccine and gene therapy applications, and Nanobodies for achieving superior tissue penetration and stability. We have comprehensive end-to-end development solutions including upstream bioprocessing optimization, downstream purification platforms, and advanced analytical characterization for all these modalities.