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
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

Clean Room Design Features

  • 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
GBF Floor Plan Facility Facility Overview CleanRooms

Utilities

    • 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

Cryogenic and Material Storage

  • 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
  • Supplier quality assurance program

Getting Started

Based on information provided by the investigator along with our “needs analysis” discovery process, we will prepare an implementation plan with scope of work and estimated cost.