Kudo Bio offers provides a complete suite of cGMP manufacturing solutions for commercial fill finish at industry platinum standards

High Versatility for Dosing Accuracy
  • Up to 200,000 Vials per day
  • Flexible vial sizes: 1 mL up to 50 mL
  • Production of 2 runs/day up to 500 vials/min
  • 100% inline visual inspection
  • Inline sterilization systems
Thorough Testing
  • Modular machine set up with barrier systems
  • All integrated and harmonized from a single source
  • Various inline inspection systems
  • Various inline inspection systems
State of the Art Technology & Facility
  • High process safety and reliability thanks to proven technology
  • Wide processing range
  • Compact GMP-compliant machine design for medium and high output rates
  • ISO 5 Compliant Isolation

Accommodates Modalities up to BSL 2
    Can accommodate various drug modalities, eg,
  • Nucleic acids (pDNA, mRNA, oligos, etc)
  • Lipid nanoparticles
  • Small molecules
  • Peptides, recombinant proteins, enzymes
  • mAbs
  • Ask about others!
Syntegon FLC 3120 for High Throughput Fill Finish

    Kudo Bio offers the top-of-the-line FLC 3120 system, a GMP-compliant industry standard with high speed, high process safety and reliability (100% IPC), wide processing area with only three format part sets, and minimal changeover times.

    Syntegon FLC3120

Syntegon AIM 3000 for Automated 100% Visual Inspection

    High-end, globally compliant system with innovative camera technology, for accurate inspection and built-in re-inspection function for higher operability and maximized false reject rate management, with both visual inspection and container closure integrity testing on one modular platform.

    Syntegon AIM3000

     Kudo Bio also offers Analytical Development, PLD, Warehousing and other support services

Package, Label, Distribution (PLD)
  • Label control & label printing
  • Secondary & tertiary packaging
  • Fully-automatic, semi-automatic and manual capabilities for commercial and clinical trial materials
  • Kit Packaging offered for single and multi-component packages, including autoinjector and safety device assembly and packaging
  • Code-reading systems for labels and folding boxes
  • Serialization and Track & Trace systems
Other Services
  • Analytical Development
  • Formulation development
  • Isolation specifications
  • PPQ capabilities and BLA/ Modified BLA support
  • Particle Monitoring compliant with ISO 4.5 (EU)
  • On-site Cold Storage warehousing available at 25°C, 2-8°C, –20°C, –80°C, with temperature control and emergency service
  • Incoming material testing & vendor qualification for commercial products
  • Media Fill Qualifications: conventional aseptic production process, including various interventions and worst-case conditions, three or more sequential and successful fills will be conducted when a new line or new process is being initially qualified
  • Potential Qualified Person (QP) Drug Product release