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Continuous processing is a buzz term that has captured the attention of the industry over the past few years. And for good reason. Experts say the method brings cost-effectiveness and greater efficiency to the drug manufacturing process.
YMC, as a pioneer in the commercialization of chromatography techniques in the medical field, is doubling down on the technique which was made clear by its recent acquisitions of ChromaCon and LEWA-Nikkiso America’s pharmaceutical systems business. Building on its core competence in HPLC and LPLC packing media and columns, YMC, with headquarters in Kyoto, Japan, acquired the two companies not only to augment its own capabilities in continuous processing but also to further strengthen its reach into the North American and European marketplaces with manufacturing-scale technology.
“YMC brings 40 years of science and innovation in the manufacture and application of purification media and hardware. The company evolved its strong presence in the academic and analytical LC arena to become a pioneer in continuous processes from the lab to the production suite,” says Gerard Gach, chief marketing officer for YMC Process Technologies’ business in Devens, MA. YMC Process Technologies was formerly known as LEWA Process Technologies (LPT). “YMC’s founder and still president and CEO, Ryuji Yamamura, targeted the industrialization of chromatography as his mission when starting the company in 1980 and the company is furthering that vision with continuous chromatography innovations.”
What was attractive about Zurich, Switzerland-based ChromaCon as an acquisition candidate was not only its portfolio of more than 30 patents, most of them centered on aspects of continuous processing and specifically around multi-column continuous chromatography, but that its intellectual property has been proven in the Contichrom® CUBE benchtop instrument family of products and is now successfully validated at the GMP production scale.
“ChromaCon is a pioneer in continuous chromatography, and it have very successfully translated that expertise into benchtop systems,” notes Gach. “Now successful up to 20 LPM with twin-column implementation at GMP production on mAbs, the team is now commercializing twin-column systems that address low yield in the fast-growing field of peptides and oligonucleotides. YMC has a novel organic/inorganic hybrid silica particle derivatized with C18 that optimizes peptide/oligo purification and when combined with ChromaCon’s MCSGP patented process provides a powerful solution that is demonstrated to up yields by threefold while decreasing buffer/solvent by 70%.”
YMC had previously built and maintained a strategic business alliance with ChromaCon by being an exclusive distributor of ChromaCon’s lab-scale systems in Japan and India, and by licensing from them technologies for GMP production–scale equipment.
The acquisition of LPT added to YMC’s current offering of chromatography columns, systems, services, and consumables. The deal assumed “all assets dedicated to the development, manufacture, and sales of batch and continuous HPLC, LPLC, SMB, and LEWA EcoPrime buffer/caustic dilution systems for the biopharmaceutical market,” according to Gach. “The cornerstone of the portfolio is the EcoPrime Twin LPLC and HPLC platform which is the GMP production-scale version of the ChromaCon technology.”
The Boston-area facility is an addition to YMC America, a standalone product distribution–based unit based in Allentown, PA.
To potential customers, what the acquisitions by YMC provide is the assurance of having a broad range of large and small molecule manufacturing technology under one corporate roof, points out Gach.
“This includes a team with the combined knowledge of packing media, separations technology, process technology, and GMP-scale systems. The group can provide insight beginning with the benchtop discovery method, through process development, and all the way to production scale,” he says.
For more information on these technologies, see: chromacon.com/en/products/gmp-scale-up-equipment