Global
CN

Mammalian
Cell Expression

Transient Expression Cell Line Development (CLD) Process Development Manufacturing PC / PV

Pilot Production (Uptream)

LKtime can meet the requirements of GMP pilot scale-up and early-stage clinical sample production (50-200L), support new drug clinical trial applications (IND) and evaluate GMP scale-up production process.

Service Contents

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.
  • Scale-up production: Small-scale production has been scaled up to pilot production (50-200L) by systematically evaluating various parameters, leveraging project experience combined with scale-up tools.
  • Main Equipment
  • Roche Blood Gas Analyzer

  • Sartorius
    Integrity Testing System

  • BECKMAN Vi-Cell
    Cell Counter

  • BioWelder TC Automatic Welding Machine

  • ThermoFisher SUB 50L Bioreactor

  • ThermoFisher SUB 250L Bioreactor