Current research activities in the unit: The primary objective of our group is to perform a complete end-to-end research for bringing a select number of protein-based biotherapeutics (biosimilar, biobetters and/or novel molecules) from a laboratory set-up to the market. Based on the disease prevalence, both globally and in the Indian context, our research will focus on developing biologics to treat cancer, rheumatoid arthritis, and childhood bronchiolitis. Efforts are ongoing to develop biosimilars of (a) adalimumab (Humira, an anti-TNF monoclonal antibody), used for treatment of rheumatoid arthritis, and (b) human Granulocyte-Colony Stimulating Factor (hG-CSF), widely used to prevent and treat chemotherapy-induced neutropenia. Our preliminary studies on the biosimilar of Humira produced by single cell clone have indicated biosimilarity with the originator molecule. In the case of hG-CSF, we are in the process of examining the biological activity and in vivo half-life of engineered versions of the G-CSF, and securing the intellectual property rights for these inventions.
The major share of the biotherapeutic market belongs to the monoclonal antibodies (mAbs) and recombinant proteins. In recent years, we have established a platform for therapeutic human mAbs production using suspension CHO cells. Various steps, including cloning of genes, transfection procedures, lab scale-up procedure to achieve high yielding single cell producers, and biophysical characterization of purified mAbs for their biosimilarity, have been optimized. In addition, we have also created polyethylene glycol (PEG) derivatives and novel variants of G-CSF using semi-rational protein evolution approaches. By employing mRNA engineering, we have improved the yield of hG-CSF production from E. coli.
Scientists: