Mumbai: Pharma major Lupin has signed an agreement with CSIR-National Chemical Laboratory (CSIR-NCL, Pune) and Department of Science and Technology, (DST, Delhi) for conducting research on a continuous purification process development of a biosimilar monoclonal antibody therapeutic (mAb).
Through this research collaboration, CSIR-NCL and Lupin would together work towards the development of a novel continuous purification process for manufacturing mAb therapeutics.
Biopharmaceuticals, biologics and monoclonal antibodies are the next wave of discovery and innovation in new pharmaceuticals.
This early research collaboration between industry and CSIR institute is expected to yield rich dividends for the country, a company statement said here.
With an increasing demand for biosimilar therapeutics and an ever-increasing pressure for manufacturing cost reduction with quality maintenance, the biopharmaceutical industry is showing a 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 limited 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 innovator’s 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.
“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 institution like CSIR is an exemplary industry-academia collaboration that can further the development and commercialization of biologics and biosimilars for a better and more affordable healthcare to customers across the globe,” Lupin senior vice president Rustom Mody said.