FUJIFILM Diosynth Biotechnologies capabilities and the MaruXTM continuous biomanufacturing platform

Time & Location

Wednesday: 14.00 to 15.00, Stage 3

Dr. Charles HeiseAssociate Director - Fujifilm Diosynth Biotechnologies

Continuous manufacturing provides a solution for uncertainty in capacity as drug candidates progress through clinical development to commercial supply.  However, adoption has been slow due to technical and operational challenges associated with managing large liquid volumes, integration of unit operations, and environmental and process controls.  We have executed the successful production of a monoclonal antibody using a 500 L scale connected process with a single-use flow path in a non-GMP pilot facility, which is a forerunner to the construction of flexible continuous GMP manufacturing facilities.

Charles Heise is Associate Director in the Bioprocessing Strategy & Development group at FUJIFILM Diosynth Biotechnologies working on developing connected, integrated processes.  He has 15 years of experience in leading the development and scale up of manufacturing processes for clinical and commercial stage biologics. He is co-inventor of the award winning SymphonXTM purification skid and the downstream technical lead for FDB’s continuous biomanufacturing process (MaruXTM). Charles has contributed to biopharma industry publications on continuous manufacturing roadmapping.