FROM START TO FINISH. ONE PARTNER.
American Injectables offers a one-stop-shop from development, including clinical phases, to commercialization for injectables in syringe, cartridges and vials.
Product Development
- QbD holistic approach
- Formulation development
- Method development for analytical and micro
- Lab scale stability
- Filter selection and compatibility
Tech Transfer
- Rapid site transfers of already developed or commercialized injectables
- Tech transfer team with optimized and tested transfer plans
- ICH stability studies
- Full analytical and micro capabilities
Drug-Device Specialists
- Experts in drug-device combination product development
- Ready to use devices such and pre-filled syringes or pens
- Fully compliant 21 CFR Part 4 streamlined QMS
Fill-Finish
- 2R-50R RTU tray vial glass or plastic
- 1 mL long, 1-3 mL, 5 mL, 10 mL, 50 mL RTU nested syringes
- 1.5 mL and 3 mL RTU cartridges
- Peristaltic and rotary piston pump filling
- Pre-configured for highly viscous
Device Assembly
- Assembly of cartridge devices for 1.5 and 3 mL formats
- Device agnostic
- Space and options for fully automated high volume assembly
Packaging and Serialization
- Serialization system integrated at line and cloud level
- Fully compliant with DSCSA current and planned requirements
- Simple process to add new products