Global
CN

Microbial Express

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

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.
  • Main Equipment
  • 500L Fermentation System

  • Pilot Production Plant

  • Cytiva BioProcess
    Modular System

  • Merck
    Ultrafiltration System