title: A Single-use Strategy to Enable Manufacturing of Affordable Biologics.
abstract: The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for best manufacturing practices. Increasing competition for new indications and the launch of biosimilars for the monoclonal antibody market have put pressure on manufacturers to produce at lower cost. Single-use technologies and continuous upstream processes have proven to be cost-efficient options to increase biomass production but as of today the adoption has been only minimal for the purification operations, partly due to concerns related to cost and scale-up. This review summarizes how a single-use holistic process and facility strategy can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for affordable biologics. Technologies enabling high productivity, right-sized, small footprint, continuous, and automated upstream and downstream operations are evaluated in order to propose a concept for the flexible facility of the future.
authors: Natrix Separations Inc., 5295 John Lucas Drive, Burlington, Ontario L7L 6A8, Canada.
authors: Renaud
authors: R
authors: Jacquemart
authors: Natrix Separations Inc., 5295 John Lucas Drive, Burlington, Ontario L7L 6A8, Canada.
authors: Melissa
authors: M
authors: Vandersluis
authors: Natrix Separations Inc., 5295 John Lucas Drive, Burlington, Ontario L7L 6A8, Canada.
authors: Mochao
authors: M
authors: Zhao
authors: Natrix Separations Inc., 5295 John Lucas Drive, Burlington, Ontario L7L 6A8, Canada.
authors: Karan
authors: K
authors: Sukhija
authors: Natrix Separations Inc., 5295 John Lucas Drive, Burlington, Ontario L7L 6A8, Canada.
authors: Navneet
authors: N
authors: Sidhu
authors: Natrix Separations Inc., 5295 John Lucas Drive, Burlington, Ontario L7L 6A8, Canada.
authors: Jim
authors: J
authors: Stout
keywords: Affinity membrane chromatography; Antibody manufacturing paradigms; B&E, bind and elute; CapEx, capital expense; CoG, cost of goods; Continuous bioprocessing; DSP, downstream process; EBA, expanded bed adsorption; EMA, European Medicines Agency; FDA, Food and Drug Administration; FT, flow through; Flexible, single-use facilities; HCP, host cell protein; MV, membrane volume; OpEx, operating expense; PAT, process analytical technology; Process economics; SMB, simulated moving bed; USP, upstream process; cGMP, current good manufacturing practice