Leading CMO purchases GMP scale multi-column units with YMC’s MCSGP continuous chromatography technology.

PRESS RELEASE

Continuous chromatography technology now planned for manufacturing suites to give CMO competitive edge with new therapies at attractive cost point

Multiple production scale units purchased

Devens, MA USA; - August, 2020

YMC will ship the first GMP scale twin-column HPLC systems enabled with the patented MCSGP (multi-column counter-current solvent gradient purification) process to a leading CMO. These first of a kind units leverage the intellectual property developed by YMC’s ChromaCon division. The process has been proven through rigorous user studies at bench scale on multiple peptides, oligos and other difficult ternary separations. The units are also designed to perform conventional single-column batch processes.

The automatic internal recycling of impure side fractions maintains the high product purity while capturing a much greater percentage of valuable product from a feed solution. A 30-60% gain in yield while reducing solvent consumption up to 70% is projected by using the proprietary continuous chromatographic process that can operate without interruption for days resulting in significant throughput gains. Operating with two identical columns, MCSGP is the simplest multicolumn HPLC technology available for center cut purifications with linear solvent gradient capabilities.

“ The adoption of YMC’s twin-column technology by yet another GMP manufacturer signals that this emerging technology is now recognized for its ability to significantly save time in production while increasing yields and productivity.” says Mark Dyment, CEO of YMC Process Technologies division. “The technology patented by ChromaCon - a YMC subsidiary - is a crucial step to extending the gains of the continuous chromatographic processes to the manufacturing suite. The CMO will gain substantial leverage with their customers seeking to produce new therapies faster and at cost effective quantities. A further attractive benefit to the CMO and their customers is reducing environmental concerns by using far less solvents during the MCSGP based purification step. ”

Enabled with the patented MCSGP technology a YMC Contichrom TWIN HPLC system also allows tremendous economic benefits to the emerging DNA / RNA based drugs and vaccines as indicated in recent studies at the bench scale. The FDA recently purchased the technology at bench scale for its further evaluation. While recording tremendous gains in productivity, solvent savings and yield, the technology maintains the purity profile required by the user. The system features linear solvent gradients.

The units are under manufacture at YMC’s Center of Excellence for GMP scale in Devens, MA USA where similar units are designed and produced within a platform of low and high pressure twin-column chromatography systems. Earlier this year to company made available a full scale twin-column HPLC GMP pilot unit and has produced multiple twin-column low pressure units used in clinical production of mAb based therapies at leading biopharmaceutical firms.