Content

MaruX™: A Continuous Process Platform for Manufacturing Monoclonal Antibodies

Part of the BTEC Fall 2022 Seminar Series

Friday, Sept. 9, 2022
10:40–11:30 a.m.
Webinar via Zoom

Speaker

Charles Heise, Ph.D.
Senior Staff Scientist, Bioprocessing Strategy and Development Group
FUJIFILM Diosynth Biotechnologies

Continuous manufacturing provides a solution for uncertainty in capacity as drug candidates progress through clinical development to commercial supply. We present a case study describing the production of a monoclonal antibody using a single-use flowpath, 500 L scale process in a non-GMP pilot facility, which is a forerunner to the construction of a continuous GMP manufacturing facility. Using our proprietary ApolloX™ high-biomass ‘perfusion ready’ cell line, combined with a commercially available single-use bioreactor operated in perfusion mode and our proprietary SymphonX™ liquid handling systems, which are used for point-of-use buffer dilution and multiple chromatography steps in a connected, intensified downstream process, we were able to process ~1 kg mAb/day.