Pilot Production (GMP production, Upsteam)
LKtime possesses commercial manufacturing facilities in Shanghai and Zhongshan that are compliant with GMP regulations. These facilities enable to offer clients a comprehensive range of services, including process scale-up, early-stage preclinical development, commercial manufacturing, and other specialized services.
Workflow
Service Features
Our 500L production line complies with Q9, Q10 and GMP regulations, enabling us to support clients with large-scale production of protein materials, meeting the requirements from preclinical to commercial production projects.
We provide a comprehensive range of process characterization services to support process validation and marketing authorization applications.
Our laboratory has successfully passed the Biosafety Level 2 (BSL-2) for microbiology laboratories and can support multi-scale (50L-500L) microbial GMP commercial production.
A 50,000 m2 manufacturing facility is under construction, focusing on the production of key clinical samples and commercial manufacturing.
The first phase of the manufacturing facility is planned to be equipped with 30L, 150L, 1000L, and 5000L×1 GMP manufacturing lines, taking into account CGT businesses such as mRNA, AAV and LV vectors.