Facility Overview
At a Glance
Facilities
- Location – Bioscience 1 12635 E. Montview Boulevard Suite 380 Aurora, CO 80045
- Space – 14,000 square ft.
Cell Processing:
- Capable of processing minimally manipulated, expanded, and genetically modified cells
- Five ISO 7 class clean rooms with ISO 5 biological safety cabinets
Quality Assurance and Control:
- Dedicated full-time Quality staff
- Electronic Quality Management System (QMS)
- Process equipment monitored/recorded wirelessly to 24/7 offsite service
- Key card controlled access
Protein Manufacturing:
- Microbial infrastructure with five- and 50-liter fermenters
- Four ISO 7 and ISO 8 class clean rooms for fermentation, purification, buffer preparation and aseptic fill
Emergency Power systems:
- Uninterruptible power supply
- Generator
- Single pass air designed for up to 60 air changes per hour
- Dedicated air handler for cGMP cell processing clean rooms
- Dedicated air handler for cGMP protein manufacturing clean rooms
- Pressurization cascade to prevent cross contamination between clean rooms
- Pressurization monitored and alarmed through an automated building management system
Utilities
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- United States Pharmacopoeia (USP)-grade purified water generation and distribution
- USP-grade gas distribution system with redundancy
- USP-grade clean steam
- ISO classified clean compressed air
- Emergency power systems for critical equipment includes a generator and an uninterruptible power supply
- Centralized, on-site cryogenic and material storage facilities
- Cryogenic storage room with ultra-low (-80 °C) freezers, controlled-rate cryopreservation freezers and liquid nitrogen vapor storage freezers
- Freezer sample management database with barcoding
- Material storage areas for both ambient and temperature-controlled conditions
- Material management database and barcoding for traceability
- Microsoft Dynamics MRP system for materials traceability