Clinical Biomanufacturing & Cell Therapy Services

Cell Therapy Process Development Services

Gates Biomanufacturing Facility (GBF) supports clients by leveraging cutting-edge technology and best-in-class talent to establish reproducible, scalable and compliant cell therapy processes that can change the future of patient care. Having development, analytical, manufacturing, logistics, quality, and regulatory under one roof allows us to plan, troubleshoot, and make decisions in a timely manner. Our PD suite is comparably equipped to both our GMP suites and QC laboratory to ensure a seamless transition to production and ensure critical quality attributes (CQA) are maintained throughout development.

Whether you have an established process or need to develop an entire process, GBF is here to help. Contact us for more information on how GBF can partner with you to have your process fully developed and manufacturing-ready
in no time!

Cell Therapy Process and Analytical Development

We offer end-to-end cell therapy process
development services:

  • Primary cell culture (T cells, NK cells, iPSC, TILs, and many others)
  • Media optimization
  • Genome modification
  • Feeder cell irradiation

Our Analytical Development Team works closely with Process Development and QC to ensure CQAs are defined and accurately measured using tools common to the industry:

  • ELISA
  • Flow cytometry
  • qPCR
  • Automated cell counting
  • Cell-based assays

We apply phase appropriate GMPs, emphasizing process control and patient safety. In other words, our state-of-the-art GMP facility and our fully trained staff are there to support cell therapy innovation, bench to bedside.

Benefits of Outsourcing to GBF

Working with GBF provides access to our best-in-class team, recruited from start-ups, commercial biologics and pharmaceutical firms around the world. This gives GBF the knowledge, flexibility, and experience to adapt and overcome the expected and unexpected challenges that accompany early-phase
cell therapies.

With ties to the University of Colorado Anschutz Medical Campus and affiliated hospitals, working with GBF not only gives you access to leading experts in the field of cell therapy, but also gives access to teams of physicians that are recognized experts in their field, to help shape your clinical trial.

Contact us for more information on how partnering with GBF will help get your therapeutic to clinic quickly and efficiently.