Gates Biomanufacturing Facility
Gates Biomanufacturing Facility is a leading-edge, academic Good Manufacturing Practice (GMP) facility located on the University of Colorado Anschutz Medical Campus. It supports the translation of research into clinical therapies, specializing in cell and biologic manufacturing for early-phase clinical trials. The facility is uniquely positioned to accelerate the development of groundbreaking cellular, gene, and protein biologic therapies, collaborating closely with researchers, clinicians, and industry partners to bring innovative treatments from bench to bedside. It also offers comprehensive biologics and cell therapy manufacturing, process development, and regulatory compliance services, serving as a critical hub for translational medicine and early-stage therapy development.
Industries
Nr. of Employees
small (1-50)
Gates Biomanufacturing Facility
Aurora, Colorado, United States, North America
Services
On-site cGMP production of clinical-grade cell therapies including manufacturing execution, QC testing and product release activities for early-phase trials.
On-site cGMP manufacturing of recombinant proteins, mRNAs, plasmids and nanoparticle-conjugated products with GMP suites, pilot-scale fermenters, chromatography and TFF systems for IND-enabling and Phase I clinical supply.
End-to-end process and analytical development services to establish scalable, phase-appropriate manufacturing processes for proteins, nucleic acids and nanoparticle products, including purification, refolding, formulation and QC method development.
Coordination and provision of plasmid DNA and GMP viral vector manufacturing capacity through strategic collaboration with external viral-vector CDMO providers to support process development and IND-enabling material supply.
Implementation and management of QA systems, SOPs, GLP/cGMP compliance, regulatory filing support and release criteria oversight for investigational biologics and cell therapy manufacturing.
Program management for outsourced manufacturing programs and academic-industry partnerships, coordinating timelines, quality, deviations, and clinical supply logistics.
On-site cGMP production of clinical-grade cell therapies including manufacturing execution, QC testing and product release activities for early-phase trials.
On-site cGMP manufacturing of recombinant proteins, mRNAs, plasmids and nanoparticle-conjugated products with GMP suites, pilot-scale fermenters, chromatography and TFF systems for IND-enabling and Phase I clinical supply.
End-to-end process and analytical development services to establish scalable, phase-appropriate manufacturing processes for proteins, nucleic acids and nanoparticle products, including purification, refolding, formulation and QC method development.
Coordination and provision of plasmid DNA and GMP viral vector manufacturing capacity through strategic collaboration with external viral-vector CDMO providers to support process development and IND-enabling material supply.
Implementation and management of QA systems, SOPs, GLP/cGMP compliance, regulatory filing support and release criteria oversight for investigational biologics and cell therapy manufacturing.
Program management for outsourced manufacturing programs and academic-industry partnerships, coordinating timelines, quality, deviations, and clinical supply logistics.
Expertise Areas
- Phase I clinical manufacturing and translation
- Cell therapy manufacturing and process development
- Biologics manufacturing (proteins, mRNA, plasmids, nanoparticles)
- Viral vector and plasmid DNA production (through CDMO partnerships)
Key Technologies
- CAR T and engineered immune cell manufacturing
- Lentiviral vector production
- Plasmid DNA production
- Microbial fermentation and bioreactors
News & Updates
Partnership to manufacture clinical supply of therapeutic NK cells, including NKX101, an investigational NK cell therapy in Phase 1 trials.
Implementation of process improvements for CAR T-cell manufacturing following FDA approval of CAR T therapies.
Facilitating the transfer of scientific innovations into clinical manufacturing to accelerate therapy development.
Insights into the clinical trial process for CAR T-cell therapies at CU Anschutz.
Ongoing clinical trial for CAR T-cell therapy targeting CD19 and CD22 in lymphoma patients.
The Gates Biomanufacturing Facility successfully produced and shipped its first clinical trial-grade cancer therapy product.
Partnership to manufacture clinical supply of therapeutic NK cells, including NKX101, an investigational NK cell therapy in Phase 1 trials.
Implementation of process improvements for CAR T-cell manufacturing following FDA approval of CAR T therapies.
Facilitating the transfer of scientific innovations into clinical manufacturing to accelerate therapy development.
Insights into the clinical trial process for CAR T-cell therapies at CU Anschutz.
Ongoing clinical trial for CAR T-cell therapy targeting CD19 and CD22 in lymphoma patients.
The Gates Biomanufacturing Facility successfully produced and shipped its first clinical trial-grade cancer therapy product.