Lupin Collaborates with CSIR-NCL and DST for Biosimilar mAb Development

Pharma major Lupin has signed an agreement with CSIR-National Chemical Laboratory, Pune (CSIR-NCL) and Department of Science and Technology, Delhi (DST) for conducting research on a continuous purification process development of a biosimilar monoclonal antibody therapeutic. All unit operations in existing manufacturing processes are currently performed in a batch mode with an overall process recovery limiting to 40–50 percent. Existing purification platforms for biosimilar mAb therapeutics involve an integration of two to three offline controlled chromatography processes which severely limits the throughput and yield of the target therapeutic product. Additionally, in comparison to the innovators drug manufacturing processes, biosimilar manufacturers also have the compulsion to match the purity profile to innovator drug molecules thereby limiting the performance of the conventional batch manufacturing processes.

Through this research collaboration, CSIR-NCL and Lupin would collaboratively work toward the development of a novel continuous purification process for manufacturing a biosimilar monoclonal antibody therapeutic (mAb). The process development team of CSIR-NCL led by Dr Rahul Bhambure will work in collaboration with the team of Lupin for developing the target process. Biopharmaceuticals, biologics, and monoclonal antibodies are the next wave of discovery and innovation in new pharmaceuticals. This early research collaboration between industry and the CSIR institute is expected to yield rich dividends for the country.