Microbiome CDMO

CKDBiome R&D
Cell bank Manufacturing
Characterization
DS Upstream/downstream
Process development
Scale-up process development
DS Formulation development
Packaging development
Analytical
method		 Verification / Validation
CKDBiome Manufacturing
Cell bank GMP system
  • MCB
  • WCB
DS GMP system
  • Engineering run
  • GMP run
  • Non-clinical
  • Phase 1
  • Phase 2
DP
CKDBiome QC
Quality test Material
Excipients
Packaging
Specification IPC
QC test
DS -75±5 ℃, -20±5 ℃,
5±3 ℃, 25±2 ℃,
30±2 ℃, 40±2 ℃
DS
Freeze - dried powder
Fermenter 250~1,250 L
Centrifuge 500~700 L/hr
Freeze dryer 50 kg
Grinder 1~5 kg/hr
Mixer 20 / 50 L
DP
Capsule (Bottle, Alu-alu)
Mixer 10 / 70 / 150 L
Capsule filler 37,000 c/hr
Coating machine 117 L/bat
PTP packing machine 25 pack/min
Bottle packing machine 8 bottle/min
Analysis
Compliance with LBP guideline
Identification test
Content of potency
Purity test
Characterization
Stability test
  • The only microbiome CDMO
    in Asia (GMP)
  • One-stop service Cell Bank → DS → DP
  • Manufacturing and quality management solutions
    by GMP systems
  • 50 Years of microbial fermentation technology
    QA/QC specialists
  • Experiencing growth in CDMO clients year after year Domestic/Global Clinical/Preclinical
  • Reasonable schedule and cost
    best(finest) partner
www.ckdbiome.com >