Global
CN

Microbial Express

Strain Construction and Seed Bank Creation Process Development Manufacturing PC / PV

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.
  • Main Equipment
  • Pilot Production Plant

  • Chromatography System

  • Solution Preparation System

  • Tofflon Process
    Chromatography System

  • Chromatography System &
    AxiChrom Shromatography Column

  • Merck
    Ultrafiltration System

  • Merck
    Virus Removal Filter System