- Best-in-class facility with unidirectional personnel and product flows
- Real time QA review and automated data acquisition
- Fully integrated inventory, EM, and Quality Management systems
- Microbiological, sterility, bioburden, B/F, endotoxin testing
- Validation of analytical test methods
- Aseptic fill and finish
- Comprehensive analytical testing capabilities
- 100% manual finished product inspection
- Logistics and supply chain support
- Flexible batch sizes, Clinical and Commercial
- Biologics
- Large and Small molecules
- Diluents
- Suspensions
- Single use or stainless steel tanks
- Line dedicated formulation suites
- Fully integrated isolator filling
- Liquid vials, 2mL- 50mL - Capacity now available
- Syringes 2mL – 10mL (planned for 2026)
- Bausch and Strobel ADVANCED fill dosing system for high yield filling (~99.9%)
- In-line non-destructive weight checks
- 40-60 units per min nominal speeds
- Ready to sterilize vials
- Full Analytical and Microbiological testing
- HPLC and UPLC
- GC
- Particulate testing
- Compendial testing of all raw materials
- Dedicated Analytical method transfer and validation resources
- ICH Stability testing