Process Development Division is responsible to perform series of process improvements or development of new processes using recombinant cell technology. The main objective of this unit is to maximize product yield, quality and product purity with streamline scale-up. Once this is achieved, transfer of technology from Process Development to Biomanufacturing could be established easily and will minimize manufacturing downtime. Process development services include scale-up of cell culture and bioreactor runs, product recovery and purification design as well as assay development.

Cell culture section is equipped with state-of-the-art bioreactors (Biostat B-DCU Twin 2 liter and twin 5 liter with Digital Touch Screen Technology) and improved version of GMP compliance SCADA data management system. These bioreactor systems have in-line physical parameter monitoring system such as pH probe, dissolved oxygen probe and temperature probe. At this Unit, cell culture is performed using several modes of operations such as batch, fed-batch and perfusion.

Perfusion culture is carried out by external spin filter device which retain viable cells and perfuse the product and cell debris out from the bioreactor. This will increase product yield at higher number of cell concentration per milliliter of culture broth and will ensure good quality products by reduction of contact time and removal of cell-bound enzyme from the culture broth. The bioprocess data from lab scale bioreactor can easily be scale-up to 20 liter bioreactor Biostat C-DCU and finally to pre-clinical bioreactor at 100 liter capacity to ensure scalability and process robustness.