Charles C. Gates Biomanufacturing Facility
UNIVERSITY OF COLORADO ANSCHUTZ MEDICAL CAMPUS | SCHOOL OF MEDICINE
The Gates Biomanufacturing Facility at the University of Colorado Anschutz Campus provides the following
services:
• Process Development
• Scale up
• Manufacturing of both cell therapy- and protein-based products, to cGMP standards
• Process documentation
We focus on delivering these services to:
• Academic researchers
• Clinicians
• Early stage biotechnology companies
Utilizing our expertise in Quality Assurance and Control and Process Development and Manufacturing, we help
translate bench scale processes to optimized clinical-ready manufacturing processes and perform product
manufacturing for early-phase clinical trials. By leveraging our existing current Good Manufacturing Practice
(cGMP) facilities, trained staff, qualified equipment and best practices across each of our support services,
investigators can significantly accelerate their timeline while minimizing their overall investment.
Facilities (14,000 sq. ft.)
Cell Therapy
Manufacturing
(silver)
Cell Therapy
Manufacturing
Protein
Manufacturing
(copper)
Cryogenic &
Material Storage
(bronze)
Protein
Manufacturing
Cryogenic &
Material Storage
Utilities
(pewter)
Quality Control Lab
(black)
Cell Dev. Lab
(nickel)
Utilites
Quality
Control Lab
Cell
Protein
Dev. Lab Dev. Lab
Protein Dev. Lab
(nickel)
Quality Assurance
Quality Assurance
(gold)
Gates Biomanufacturing Facility
•
12635 E Montview Blvd. Suite 380
•
Aurora, CO.80045
2
Cell Therapy Manufacturing (silver):
•
Five ISO7-grade cell processing suites that operate at 20 to 60 air changes per hour with single-pass, HEPAfiltered air supplied by a dedicated air-handling unit.
Each suite is equipped with one or two biological safety cabinets, tabletop centrifuge, multiple HEPA-filtered
tissue culture incubators, and other specialized cell processing instruments.
4
1
Exhaust Air Out
2
Filtered Air In
3
HEPA Filter
4
Dedicated Air Handler
5
Filters Covering 20-30% of Ceiling
6
Class 10000 Cleanroom Space
Single Pass Air
2
5
Ducting
1
3
HEPA Filter
5
1
Ducting
•
6
Protein Manufacturing (copper):
•
•
Four ISO7- and ISO8-grade manufacturing suites
that operate at 20 to 40 air changes per hour with
single-pass, HEPA-filtered air supplied by a dedicated
air-handling unit.
Suites are dedicated and equipped for buffer
preparation, microbial fermentation (maximum
vessel working volume of 50 liters) and clarification,
protein purification, and aseptic formulation and fill of
product.
Cryogenic and Material Storage (bronze):
•
Centralized cryogenic and material storage facilities.
•
Material storage areas are equipped to store materials at ambient or temperature-controlled conditions.
•
Cryogenic storage room is equipped with ultra-low (-80 °C) freezers, controlled-rate cryopreservation
freezers, and liquid nitrogen vapor storage freezers.
Quality Control Laboratory (black):
•
State-of-the-art analytical equipment for sterility, mycoplasma and endotoxin testing, environmental
monitoring, and characterization of cell therapy and protein products.
Gates Biomanufacturing Facility
•
12635 E Montview Blvd. Suite 380
•
Aurora, CO.80045
3
Process Development Laboratories (nickel):
•
Laboratories for cell therapy and protein process development.
•
Equipped to mirror equipment centers in the manufacturing cleanrooms.
Utilities (pewter):
•
Back-up power for the facility’s critical equipment include a generator and an uninterruptible power supply.
•
USP-grade water generation and distribution system.
•
Medical-grade gasses, air, and steam distribution system.
Quality Assurance (gold):
•
Provides oversight of all manufacturing and facility operations through a comprehensive quality management
system tailored to meet regulatory requirements for protein-based biologics and cell-based products.
•
Utilizes a quality management software system.
Gates Biomanufacturing Facility
•
12635 E Montview Blvd. Suite 380
•
Aurora, CO.80045
4
Partners
Colorado School of Medicine
UNIVERSITY OF COLORADO ANSCHUTZ MEDICAL CAMPUS
We gratefully acknowledge the Gates Frontiers Fund as the leading contributor to the Charles C. Gates Center
for Regenerative Medicine and Stem Cell Biology in support of the Gates Biomanufacturing Facility.
Getting Started –Technical Assessment
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. This assessment will be a valuable tool
in planning a regulatory approval path as well as documenting financial support requirements.
Contacts:
Thomas Payne Ph.D, Director of Cell Therapies - thomas.payne@ucdenver.edu - 303.724.7779
Patrick Gaines, Business Development - patrick.gaines@ucdenver.edu - 720.281.2100
Timothy Gardner, Business Development - timothy.gardner@ucdenver.edu - 303.724.7049
Gates Biomanufacturing Facility
•
12635 E Montview Blvd. Suite 380
•
Aurora, CO.80045
5