Devens, MA, USA / Zurich, Switzerland – July 2020 – The U.S. Food and Drug Administration (FDA) has selected the YMC Contichrom® CUBE, a twin-column continuous chromatography system from YMC ChromaCon, to evaluate advanced continuous purification strategies for biopharmaceutical manufacturing.
The FDA’s acquisition of the Contichrom CUBE underscores growing industry and regulatory interest in continuous chromatography to reduce costs, increase productivity, and maintain high product quality for both small and large molecule therapeutics.
Continuous Twin-Column Chromatography Platform Chosen by FDA
The FDA has ordered a development-scale YMC Contichrom CUBE system equipped with YMC’s patented twin-column processes:
- MCSGP – Multi-Column Countercurrent Solvent Gradient Purification for semi-continuous gradient separations of peptides, oligos and other complex molecules.
- CaptureSMB – Twin-column continuous capture chromatography for mAbs and other biologics.
The bench-top unit also includes AutoPeak and AutoMab dynamic process control software and is capable of:
- Conventional single-column batch chromatography
- Sequential orthogonal (pool-less two-step polishing) chromatography
- Unique N-Rich processing for challenging separations
MCSGP = multi-column countercurrent solvent gradient purification.
Proven Performance for Biologics and Advanced Therapies
The Contichrom CUBE platform embodies YMC’s intellectual property for twin-column continuous chromatography, already implemented at numerous GMP producers of monoclonal antibodies (mAbs), vaccines, peptides, oligonucleotides and other advanced biotherapeutics in the USA, Europe and Asia.
Users report significant performance advantages when applying YMC’s patented processes:
- MCSGP for peptides and oligos: 30–60% gains in product yield while reducing solvent consumption by up to 70%, thanks to automated internal recycling of impure side fractions.
- CaptureSMB for mAb-based therapies: Scaled from CUBE to production processes exceeding 20 L/min, with reductions in Protein A resin and buffer consumption by up to 60% and productivity increases of up to 3× versus conventional single-column batch capture.
These gains are achieved while maintaining the high product purity demanded for clinical and commercial biopharmaceutical production.
Supporting the Transition to Continuous Bioprocessing
The FDA has long encouraged the adoption of continuous processing across the pharmaceutical and biopharmaceutical industries. With the YMC Contichrom CUBE, FDA scientists and academic collaborators will be able to generate additional data, case studies and best practices to support broader implementation of continuous chromatographic processes.
“The acquisition of YMC’s twin-column technology by the FDA is welcome and signals that this emerging technology will be evaluated by the world’s leading regulatory authority for its ability to significantly reduce costs through improved process efficiency, while maintaining product quality,” says Mark Dyment, CEO of YMC Process Technologies, the USA-based supplier of the Contichrom CUBE instrument.
“The scalable technology, patented by YMC ChromaCon and already in use by many of the industry’s largest drug manufacturers, in the hands of the FDA will add further insights on continuous chromatographic processes for customers seeking to produce new therapies at cost-effective quantities.”
The Contichrom CUBE units are manufactured in the USA and will be finally assembled at YMC’s Center of Excellence for GMP scale in Devens, Massachusetts, before shipment to the FDA’s laboratories in Maryland.
Key Benefits of YMC Twin-Column Continuous Chromatography
- Higher yield: Automated internal recycling recovers valuable product from overlapping peak regions that are typically discarded in batch chromatography.
- Lower solvent and buffer usage: MCSGP and CaptureSMB can significantly reduce solvent and buffer consumption, lowering overall cost of goods.
- Increased productivity: Continuous operation and higher effective loading lead to throughput gains of up to several-fold compared with single-column batch processes.
- Scalable from lab to GMP: Processes developed on the Contichrom CUBE can be scaled to clinical and commercial production using YMC’s GMP-scale systems.
About YMC
YMC Co., Ltd. is a privately held life science company headquartered in Kyoto, Japan. Founded in 1980, YMC operates more than nine affiliates and facilities across Asia, Europe and the Americas, employing over 500 people dedicated to providing best-in-class laboratory and process solutions to the bio/pharmaceutical industry.
YMC’s core expertise includes the innovation, production and sale of packing materials, packed columns and systems for high performance liquid chromatography (HPLC), low pressure liquid chromatography (LPLC), and custom purification and synthesis. The company operates a contract manufacturing (CMO) facility and recently opened “Kyoto Works,” a state-of-the-art lab and pilot site focused on multi-column purification and process scale-up.
YMC Process Technologies (YPT) in Devens, MA, USA has supplied GMP-scale downstream process systems for nearly 20 years. Acquired by YMC in 2018, the YPT Bio/Pharma Systems Group, together with its sister affiliate YMC ChromaCon in Zurich, is a leading provider of lab and production-scale single- and multi-column chromatography systems. YMC’s intellectual assets and deep application know-how support the purification and discovery of next-generation small and large molecule therapies.
Media Contact
For additional information about this press release and YMC twin-column continuous chromatography solutions, please contact:
- Dr. Thomas Müller-Späth, Director R&D, YMC ChromaCon AG – – www.chromacon.com
YMC is a registered trademark of YMC Co., Ltd. Contichrom is a registered trademark of YMC ChromaCon AG.
