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Drug Product MFG.

Item What We Have, Do, Provide
Formulation Development
  • Established a DOE-based exipients screening platform accompanying with critical analytical parameters in stressed storage system.
Process Development
  • Container selection for parental use.
  • Experienced in lyophilization parameters development.
  • Experienced in process development for prefilled syringe and vial.
Liquid (vial)
  • Complied with PIC/S GMP.
  • Capacity fitted for clinical trial.
  • Validated process: 1,500~5,000 vials / lot (2R~20R vial).
  • Expandable to commercial scale.
Lyophilized Powder for Injection (vial)
  • Complied with PIC/S GMP.
  • Capacity fitted for clinical trial.
  • Validated process: 3,200 vials / lot (2R vial).
Liquid (Prefilled Syringe)
  • Capacity fitted for clinical trial.
  • Validated process: 4,000 syringes / lot (0.5~2.25 mL).
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