cGMP Drug Substance Manufacturing
cGMP Drug Substance Manufacturing Services
Pharmaron’s biologics manufacturing plant provides cGMP manufacturing services to global clients. The plant includes two trains: Train 1 is for Phase l/ll clinical trial materials and Train 2 is for Phase III and small-scale commercial products. Each train includes drug substance manufacturing lines with matching downstream processing equipment. All upstream processing (USP) and downstream processing (DSP) equipment is from Cytiva.
Train 2’s DSP equipment provides in-line conditioning (IC) that will be used to simplify buffer preparation which allows in-line dilution, in-line pH adjustment, in-line conductivity measurement and in-line release of buffers for AC, AEX and CEX steps.