GMP-scale system enables advanced purification of peptides, oligos, RNA, and dsDNA based therapies and vaccines on a continuous basis.
Allentown, PA -- (SBWIRE) -- 12/21/2020 -- A state-of-the-art lab, with a focus on developing continuous purification technologies, that was inaugurated in November 2019 will be home to the first-of-a-kind continuous HPLC. Named "Kyoto Works," the 2,600m2 facility is owned by YMC in Fukuchiyama, near Kyoto, Japan.
The lab is now readying to accept a production scale Contichrom TWIN 300 HPLC enabled with the patented multi-column countercurrent solvent gradient purification (MCSGP) technology. This twin-column HPLC system is the largest of its kind in the world and will be available for customer use as well as in-house development work. It joins the multiple Contichrom CUBE bench top units, which have the MCSGP functionality, already in use at the Kyoto Works facility. Uniquely, the unit is engineered to operate both as an HPLC designed to 100 bar as well as perform LPLC tasks such as ion-exchange chromatography. A smaller-scale pilot GMP unit is available in the USA.
Using the proprietary semi-continuous chromatographic process of MCSGP, users report 30-60% gains in yield while reducing solvent consumption up to 70% during purification of peptides and oligos. The MCSGP process works by automatically alternating the feeding of one of two identical columns while eluting the other column. The automatic internal recycling maintains the high product purity while purifying a much greater percentage of valuable product from a feed solution.
In its inaugural year, the YMC Kyoto Works lab is operating in Phase I of a multiple phase roll out of capabilities. In Phase I, the facility has lab to mid capacity DAC (dynamic axial compression) column manufacturing (300~600?) and houses three (3) Contichrom CUBE instruments, an EcoPrime six (6) column simulated moving bed (SMB) HPLC, an SMB lab instrument, a Contichrom TWIN CaptureSMB 100 GMP scale LPLC, and a 1000?DAC system.
The TWIN MCSGP unit adds its 0.3 to 3.3 LPM capacity to the already impressive array of technologies available in the YMC Kyoto Works. Phase II of Kyoto Works lab will see up to 200 employees with manufacturing capacity, and an additional building (explosion-proof/GMP) is planned for completion in 2021 on the 52,000 m2 of YMC owned land.
"The addition of another of YMC's patented twin-column technology to our Kyoto Works facility at the GMP scale signals further commitment to enabling our customers access to continuous purification of vaccines and therapies," says Ryuji Yamamura, CEO of YMC. "Since the acquisition of ChromaCon AG in 2019, YMC has quickly brought the technology of continuous chromatographic processes to market at production scale through internally funded investment. YMC's commitment to bring this scale to industrial manufacturing processes is core to our mission and continues our heritage as a pioneer in chromatography. The user of such systems will gain substantial leverage in producing new therapies at cost-effective quantities. Further, the owners will be reducing environmental concerns by using far less solvents — an attractive benefit in the reduction of greenhouse gases."
Recently the USA's FDA acquired YMC's twin-column technology for evaluation, and a major GMP producer in the EU has placed orders for two (2) larger versions of the Contichrom TWIN HPLC MCSGP enabled systems. These units are scheduled for GMP production of peptides and oligo based drugs in early 2021.
The Contichrom TWIN units are manufactured in the USA at YMC's Center of Excellence for GMP scale systems in Devens, MA, where other pilot scale units are available for customer evaluation. The capability to manufacture the same systems is being developed in YMC's Japanese manufacturing sites.
The YMC Contichrom TWIN HPLC system enabled with the patented MCSGP technology now is seen to have tremendous economic benefits to the emerging DNA/RNA based drugs and vaccines as indicated in recent studies at the bench, which has piqued the interest of those working with novel RNA and DNA approaches to COVID vaccines. The rapid uptake of this technology and the additional insights gained at Kyoto Works bodes well for the future of this and other YMC products.
Visit https://www.ymcamerica.com/ to learn more about YMC's state-of-the-art lab and to purchase UHPLC and HPLC columns, or speak with a YMC America representative by emailing info@ymcamerica.com or calling 888-341-8380.
About YMC America, Inc.
Established in 1980, YMC America, Inc. is worldwide full-service liquid chromatography company, which offers sales, technical product support, service, application assistance, purification services, contract synthesis and method development.
All YMC products are available worldwide through YMC's network of subsidiaries. This worldwide presence as a full-range chromatography supplier ensures that all YMC products are fully available and fully supported both locally and globally.
See: https://www.ymcamerica.com/