Injectables Manufacturing

Rigorous Risk Control for Cytotoxic Drugs

Our injectables team brings innovative cancer treatments from the laboratory to the public in safe, effective forms with the utmost attention to product quality and safety.

 

Quick Facts:

  • PIC/S GMP certified facility in Yunlin, Taiwan
  • Launched in 2018, US and Taiwan FDA certification expected early 2021
  • Specializes in cytotoxic oncology drugs
  • Utilizes best-in-class technologies and sterilization processes to meet the high product quality and safety standards of this complex market
  • 123,318 square feet
  • Trade Agreement Act compliance meets U.S. requirements for trade with the U.S. government

 

Formulation development capabilities include working with:

  • Oncology dosage forms
  • Potent APIs
  • Poor solubility and high toxicity APIs
  • Controlled and modified release technologies
  • Multi-characteristic drug delivery systems

Specialty technologies:

  • Fully integrated isolator to ensure sterile production from filling to lyophilization
  • Drug delivery platforms specializing in:
    - liposomes
    - emulsions
    - suspensions
    - microspheres
    - nanoparticles

Key formulation techniques:

  • High shear homogenization
  • Microfluidization
  • Extrusion
  • Lyophilization
  • Tangential flow filtration
  • Sterile filtration

Best-in-Class Services At-a-Glance:

  • Manufacturing capacity:
    - 2, 5, 10, 20, 30, 50 mL vials
    - 0.5-50 mL fill volume
  • Supports a variety of development programs:
    - 1 Aseptic automated filling line
    - 1 Lyophilizer (2R, 6R, 10R, 20R, 30H, 50H vials)
    - Terminal sterilization: up to 20,500 vials
    - Flexible cleanrooms
    - Cytotoxic chemicals handling
  • Efficient scale-ups for each stage
    - Batch sizes: 2,500-24,000 vials/batch
    - Customizable processes for preclinical, clinical, and commercial products
  • Quality assurance
    - In-house analytical services
    - Periodic internal audits to maintain cGMP compliance
  • State-of-the-art equipment:
    - Bosch, Getinge, IMA, Stilmas,  SKAN,Waldner