Pilot Production (Uptream)
LKtime can meet the requirements of GMP pilot
scale-up and early-stage clinical sample production (50-200L), support new drug
clinical trial applications (IND) and evaluate GMP scale-up production process.
Service Contents
Service Features
A comprehensive complete document quality management system has been implemented in accordance with Sino-US declaration requirements.
One pilot production line compliant with GMP
standards has been established and is fully equipped with imported bioreactors.
State-of-the-art liquid preparation and storage systems, as well as testing equipment, have been employed.
Scale-up production: Small-scale production has been scaled up to pilot production (50-200L) by systematically evaluating various parameters, leveraging project experience combined with scale-up tools.