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.
A diverse group with expertise in tech Transfer, Process Development, and Manufacturing according to good laboratory principles (GLP) and current Good Manufacturing Principles (cGMP) for Phase 1 human clinical trials. The group specializes in E. Coli based recombinant protein therapies with special emphasis on refolding of inclusion bodies, nanoparticle conjugates and mRNA production. The group is always looking to increase novel biomolecules development capabilities and, in the pipeline, including nucleic acid and antibody therapies.
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
BIOLOGICS MANUFACTURING
- Microbial Infrastructure – E. Coli
- 50 liter working volume fermenter w/ sterilization-in-place (SIP), clean in place (CIP) skid
- Pilot scale electric-hydraulic Microfluidizer
- Three ISO 5 Biological safety cabinets
- GMP dishwasher and ultrasonicator
- Two ISO 7 and four 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, biologics drug product manufacturing, purification and further modification, aseptic formulation, fill of bulk drug substance
- Two 50 liter and one 200 L Magnetic mixer for solution preparation
- Purification – AKTA PILOT, 0.25-to-2-liter column chromatography capability
- Ultra-Filtration/Tangential-Flow Filtration- Sartoflow pre-sterilized single use system
BIOLOGICS PROCESS DEVELOPMENT
- Bench to GMP 1:10 pilot scale seamless process transfer
- Two – 5-liter Microbial Fermenters
- Purification: AKTA PURE FPLC, Preparative HPLC
- Shaker/incubator
- Two ISO 5 biological safety cabinets (BSCs)
- Tangential flow filtration system
- Micro fluidizer
- High pressure refolding capability
- Nucleic acid synthesis, purification, and modification
- Other biological therapeutic reagent preparation, purification, and conjugation
Biologics Analytical Assay Development
- HPLC, DLS, SEC-MALS, ELISA, qPCR, Endotoxin, Spectrophotometer
QUALITY CONTROL – BIOLOGICS 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