India:CSIR-NCL And DST Sign An Agreement With Lupin For Biosimilar

CSIR-National Chemical Laboratory (CSIR-NCL, Pune) and the Department of Science and Technology (DST) have signed a collaboration agreement with Lupin Ltd. for a continuous purification process development of a biosimilar monoclonal antibody (mAb) therapeutic.

mAbs represent the most important biopharmaceutical product class, serving the high-demand treatment area of immuno-oncology diseases. With an increasing demand for biosimilar therapeutics and an ever-increasing pressure for manufacturing cost reduction with quality maintenance, the biopharmaceutical industry is showing keen interest in the development of continuous manufacturing processes. All unit operations in existing manufacturing processes are currently performed in a batch mode with an overall process recovery limiting to 40-50%. 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 molecule, thereby limiting the performance of the conventional batch manufacturing processes.

Through this research collaboration, CSIR-NCL and Lupin Ltd. would collaboratively work towards the development of a novel continuous purification process for manufacturing a biosimilar mAb. The process development team of CSIR-NCL lead by Dr. Rahul Bhambure will work in collaboration with the team of Lupin for developing the target process, said Prof. Ashwini Kumar Nangia, Director, CSIR-NCL.

Speaking about the partnership, Dr. Rustom Mody, Senior Vice President and Head – R&D, Biotechnology, Lupin said, “Biotech is one of Lupin’s key growth drivers and we are committed to advancing our biotech R&D capabilities through strategic partnerships. Our collaboration with a premier CSIR institution is an exemplary industry-academia collaboration that can help further the development and commercialization of biologics and bio-similars for a better and more affordable healthcare to customers across the globe.”

Prof. Nangia, DST representative, Dr. C. Rajadurai and Dr. Mody signed the agreement on Feb 6, 2018.