Lupin signs an agreement with CSIR-NCL and DST for the development of a continuous manufacturing process for biosimilar monoclonal antibody therapeutic (mAb)

Mumbai, March 08,2018: Pharma major Lupin today announced the signing of 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.

Monoclonal antibodies 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.