YMC America, Inc.

YMC Announces Formal Study of Large-Scale Production of Specialty Peptide Drug API with Continuous Chromatography System

PeptiDream and YMC groups announce a formal joint-task group to scale successful lab work to multiple GMP production lines for specialty peptide drug products at the main factory of PeptiStar Inc. YMC’s patented twin-column technology will be a key technology in the venture. Work is anticipated to result in the implementation of the technology on a large scale in late 2021.

 

Devens, MA -- (SBWIRE) -- 03/04/2021 -- YMC CO., LTD. (YMC) has formalized a joint-study to scale continuous chromatography technology to the purification process at mass production scale of peptide-based therapeutic drugs with PeptiDream Inc. and PeptiStar Inc. PeptiDream Inc. and PeptiStar Inc. are developers and manufacturers of specialty peptide therapeutics. Extensive lab studies using YMC's twin-column continuous chromatography technology showed great improvement in the productivity of these highly valuable drug substances. Further studies will be conducted at the main factory of PeptiStar Inc. (Settsu, Osaka), where the same technology proven at research scale will be implemented on a production scale system designed for GMP manufacturing. YMC expects to have a full-start of the industrial scale work by the end of 2021.

The joint-study group is presently using the lab results at PeptiStar for further optimization of a GMP compliant larger scale twin-column continuous chromatography system, known as "Contichrom TWIN." There are multiple production lines for specialty peptide drugs at the main factory of PeptiStar Inc. (PeptiDream Inc. is a key investor in PeptiStar Inc.). Currently, conventional single-column chromatography systems are used in all purification processes. This will be the first case in Japan for both YMC and PeptiStar/PeptiDream for multi-column purification technology at production scale.

YMC has significantly increased resources for the development of continuous chromatography technology used in the preparative purification process of smaller drug molecules such as peptides and nucleic acids, as well as larger antibody drugs for the biopharmaceutical industry. Following the take-over of the related business from LEWA-Nikkiso America, Inc. in 2018, YMC gained twin-column continuous chromatography systems for research and for industrial use, which enable recovery of the target object in high efficiency and high purity, by purchasing ChromaCon AG (Zurich) in April 2019. YMC also manufactures packing materials and columns, which are essential to these systems.

The continuous chromatography systems attract attention from domestic/international major pharmaceutical companies. While many of those systems for research are already introduced domestically and internationally, the systems for industrial use are also starting to receive orders, including from European and American pharmaceutical companies. Last year, the Food and Drug Administration (FDA) purchased the bench-scale system for the purpose of evaluating the quality of the variety of pharmaceutical products manufactured using a continuous production system.

Visit https://www.ymcamerica.com to learn more or to purchase UHPLC and HPLC columns and other preparative chromatography materials.

About YMC
YMC is a private life science company headquartered in Kyoto, Japan. Founded in 1980, YMC has 9 affiliates and facilities in Asia, Europe, and the Americas. Over 500 YMC employees are providing best-in-class lab and process solutions to bio/pharmaceutical industry.

YMC delivers and supports these solutions in all major global geographies on six continents.

YMC's focus is on innovation, production, and sales of packing materials, packed columns, and systems for High Performance Liquid Chromatography (HPLC), Low Pressure Liquid Chromatography (LPLC) and custom purification and custom synthesis.

YMC operates a CMO facility and pilot plant incorporating state of the art simulated moving bed (SMB) purification.

YMC America has been in operation over 30 years serving the Americas. In 2019, YMC acquired the former LEWA Process Technologies (Devens, MA USA) and ChromaCon AG (Zurich, CH).

YMC's intellectual properties, cultivated from many years of experience, will continue to push the limits to create a prosperous future for purification and discovery of small and large molecule therapies.

See: https://www.ymcamerica.com/