At-a-Glance
Our 87,000-sq. ft. Camden facility in Baltimore, MD (USA) provides drug product manufacturing for sterile injectables. The site offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.
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
- Current annual capacity:
- Filling = 6.8 million+ units
- Packaging = 5.2 million+ units
- 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 (lyo ready Q1 2022)
- 1mL pre-filled syringes (Q1 2022)
- 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
