Pilot Production (Downsteam)
LKtime is actively striving to position itself
as a leading biopharmaceutical CDMO. It has successfully established a
mature purification pilot production platform.
Workflow
Service Features
We have a 350m2 pilot plant for drug substance manufacturing that is compliant with cGMP standards.
We are equipped with 2 GMP-like drug substance production lines (1×200L, 1×500L), featuring multiple chromatography systems (1L pilot scale, 3L process scale), GEA disc centrifuges, GEA homogenizers, and fully automated integrated crude purification equipment to cater to clients’ production requirements across various projects.
Offering process scale-up and GMP early clinical sample production services, encompassing process transfer, optimized production scale-up strategies, risk assessments and GMP manufacturing.
Non-GMP drug substance can be manufactured for drug feasibility studies, process development and IND application.
Providing samples can be produced for subsequent process characterization and validation.