Our capabilities at a glance

Highlights
  • Best-in-class facility with unidirectional personnel and product flows
  • Real time QA review on Electronic Batch Records with automated data acquisition
  • Fully integrated inventory, LIMS, EM, and Quality Management systems
  • Microbiological, sterility, bioburden, B/F, endotoxin testing
  • Development and validation of analytical test methods
Services & Processes
  • Aseptic fill and finish
  • Terminal sterilization
  • Comprehensive analytical testing capabilities
  • 100% manual finished product inspection
  • Logistics and supply chain support
Formulation
  • Flexible batch sizes, Clinical and Commercial, Class I-III
  • Biologics
  • Small Molecules
  • Diluents
  • Suspensions
  • Single use or stainless steel tanks
  • Fully aseptic compounding
  • Line dedicated formulation suites
Filling
  • Fully integrated isolator filling
  • Lyo (planned for 2023) and Liquid vials, 2mL- 20mL
  • Syringes 2mL – 10mL
  • 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 use and ready to sterilize vial processes
Analytical Support
  • 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