Baltimore

Formulation Capabilities

• Extensive experience with filling of viscous and non-viscous solutions/suspensions
• Expertise with both small molecule and biological compounds
  • Small and large molecule sterile drug product capabilities
• Handling of products with stability challenges such as:
  • Sensitivity to light (use of amber light and amber vials)
  • Sensitivity to oxygen (i.e., N2 overlay)
• Extensive expertise in lyophilization development, optimization, and commercialization for both vials and syringes.

Manufacturing Capabilities and Technologies

• Clinical and commercial non-viral GMP DP manufacturing
  • Chase-Logeman® 2 Headed High Speed Line
    • 2ml-100ml vials
    • Up to 60,000 vials/batch
  • Chase-Logeman® Single Headed Fill Line
    • 3mL - 100 mL vials
    • Up to 21,600 vials/batch
  • Groninger® FlexPro 50 flexible isolator fill line
    • 2R and 10R vials
    • 1mL pre-filled syringes 
    • Integrated loading/unloading
    • Employs ready-to-use components
    • Integrated lyophilizer
  • Inova® 2 Headed Syringe Line
    • 0.5mL - 20mL pre-nested syringes
    • Up to 13,200 syringes/batch
  • 3 Lyophilization units
  • Terminal sterilization services
• Support services
  • Raw material testing
  • Finished product release testing
  • Stability testing
  • Packaging: serialization and aggregation services
  • Visual inspection
  • Large capacity cold storage: 2-8°C cold room; -20°C and -70°C freezer storage
• Centralized warehouse