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LKtime Biotech (Changchun)

R&D Center Drug Substance (DS) production Drug Product (DP) production Quality Analysis and Control Customized CDMO Service

Multifunctional DP filling line

LKtime Biotech (Changchun) has established an advanced "all-in-one" multifunctional DP filling line, rigorously compliant with the high GMP standards of NMPA, FDA, and EMA. Leveraging exceptional flexibility and cutting-edge technology, this line seamlessly adapts to diverse biopharmaceutical manufacturing needs, including antibody therapeutics, antibody-drug conjugates (ADCs), recombinant proteins, and vaccines, ensuring highly efficient and precise production process management. Additionally, the line fully accommodates three primary dosage forms - vials, pre-filled syringes, and cartridges - providing comprehensive solutions for varied biologics DP requirements.

Drug Product Specifications

  • Vials: 2R-50R
  • Prefilled syringes: 0.5mL-20mL,1mL-long
  • Cartridges: 1.5mL、1.8mL3mL
  • High-Precision Filling (with integrated IPC for aqueous viscous solutions)

  • 0.1mL-0.3mL: ≤ ±5%
  • 0.3mL-0.5mL: ≤ ±3%
  • 0.5mL-1mL: ≤ ±2%
  • 1mL-2mL: ≤ ±1.5%
  • 2mL: ≤ ±1%
  • Filling Capacity

    Filling Capacity
    Main Equipment
  • Multifunctional DP filling line

  • 6-Axis articulated robot