FACILITY & CAPIBILITIES

FACILITY & CAPABILITIES

HOW WE CAN HELP

Built among the research labs of the Anschutz Medical Campus and just a stone’s throw from two major hospitals, the GBF was designed to bridge those two worlds as a state-of-the-art Good Manufacturing Practice (GMP) facility. Since it’s opening in 2015, GBF has done just that, accelerating protein biologic and cell therapy translation into treatments that have improved and saved lives.

CELL THERAPY

CELL PROCESSING

  • Five – ISO 7 class clean rooms
  • Biological safety cabinets in each clean room with procedures in place to handle gene-modified therapies.
  • Clean rooms operate at a minimum of 30 air changes per hour with single-pass HEPA-filtered air supplied by a dedicated air-handling unit
  • CO2 and O2 controlled incubators
  • CliniMACS® Prodigy System
  • Sepax C-Pro Cell Processing System
  • Automated cell counter – trypan blue, fluorescent dye compatible
  • Process Development equipment mirrors cGMP cell processing equipment for seamless process transfer – 1:1 scale

 

CRYOGENIC AND MATERIAL STORAGE

  • Cryogenic storage room with ultra-low (-80 °C) freezers, controlled-rate cryopreservation freezers and liquid nitrogen vapor storage freezers
  • Freezer sample management database
  • Material storage areas for both ambient and temperature-controlled conditions
  • Microsoft Dynamics MRP system for materials traceability

BIOLOGICS

PROTEIN MANUFACTURING

  • Microbial Infrastructure – E. Coli
  • 50 liter working volume fermenter w/ sterilization-in-place
  • Clean-in-place skid
  • Four ISO 7 and ISO 8 clean rooms operating at a minimum of 30 air changes per hour with single-pass HEPA filtered air supplied by a dedicated air handling unit
  • Clean rooms for buffer preparation, clarification, protein purification, and aseptic formulation and fill of bulk drug substance
  • Two – 50 liter magnetic mixers for buffer preparation
  • Purification – .25 to 2 liter column chromatography capability in both
  • Ultra-Filtration/Tangential-Flow Filtration

 

PROTEIN PROCESS DEVELOPMENT

  • Equipment mirrors cGMP processing equipment for seamless process transfer – 1:10 scale
  • Two – 5 liter Microbial Fermenters
  • Purification: AKTATM PURE, AKTATM PRIME
  • Shaker/incubator
  • Tangential flow filtration system
  • Micro fluidizer
  • High pressure refolding capability

 

QUALITY CONTROL – PROTEIN MANUFACTURING

  • HPLC/UPLC systems
  • UV-Vis spectroscopy
  • SDS-PAGE
  • ELISA and cell-based assays
  • Real-time thermocycler
  • Residual host cell DNA
  • Biophysical and mass spectrometer characterization using CU Anschutz Medical Campus core facilities

QUALITY CONTROL

QUALITY CONTROL – CELL PROCESSING

  • Real-time thermocycler – Gene expression, Mycoplasma
  • Flow cytometry – ten colors, three lasers
  • Automated cell counter – trypan blue, fluorescent dye compatible
  • Microscopy – brightfield, phase, fluorescence
  • Microplate reader with high-content cell imaging
  • ELISA/Cell-based assays
  • All pertinent safety assays

 

QUALITY CONTROL – PROTEIN MANUFACTURING

  • HPLC/UPLC systems
  • UV-Vis spectroscopy
  • SDS-PAGE
  • ELISA and cell-based assays
  • Real-time thermocycler
  • Residual host cell DNA and pertinent safety assays
  • Biophysical and mass spectrometer characterization using CU Anschutz Medical Campus core

 

QUALITY CONTROL – MICROBIOLOGY

  • Dedicated microbiologists
  • Endotoxin testing
  • Bioburden testing
  • Mycoplasma testing
  • Microbial air sampling
  • Non-viable particle analyzers

FACILITY FLOOR PLAN