GMP Commercial Production
LKtime is equipped with a GMP-compliant production
line capable of handling volumes ranging from 50L to 2000L. The line features state-of-the-art
imported equipment from Sartorius, including 20L/50L RM bioreactors
and 200L/2000L SUB bioreactors. The facility is capable of providing clinical
and commercial drug substance manufacturing services.
Workflow
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.
The professional team has abundant experience in GMP commercial production.