Gates Biomanufacturing Facility
directed by Ryan Crisman PhD
http://www.gatesbiomanufacturing.com
a member since 2/11/2016

Contact Info

For information contact
Timothy Gardner.

303-884-9056
University of Colorado-School of Medicine
12800 East 19th Avenue
Mailstop 8320
Aurora, CO 80045

USA

Services Provided

offers production support to both Academics and Companies.

Misc Services

  • process development
  • product manufacturing
  • characterization
  • storage
  • distribution
  • Regulatory consultation
  • Quality control
  • Quality assurance

Biologics Produced

  • recombinant proteins from bacteria and yeast
  • Recombinant Proteins
  • Pluripotent Stem Cells
  • mesenchymal stromal cells
  • Isolation and culture of human fibroblast
  • Human iPS cells
  • Hematopoietic Progenitor Cells
  • full GMP facility. Master cell banks
  • Bacteria

Vector Support

  • Yeast and bacterial systems
  • Pichia pastoris and E. coli

About this facility

The Gates Biomanufacturing Facility at the University of Colorado Anschutz Medical Campus is a 14,000 square ft. GMP compliant manufacturing facility that provides cell-based therapies and protein biologics for use in preclinical investigations and Phase I and Phase II human clinical trials. The GBF was established in 2015 though partnership with the Gates Center for Regenerative Medicine, University of Colorado Health, Children's Hospital of Colorado, University of Colorado-School of Medicine, and the Gates Frontiers Fund. 

Our Mission is to accelerate the translation of scientific discoveries into human clinical trials as safely, efficiently, and cost effectively as possible according to high quality standards. We serve academic researchers, clinicians, early stage biotechnology companies and established pharmaceutical companies throughout the US.

In connection with our manufacturing, we provide the following services:
1. Cell therapy and Protein product process development and scale up
2. Cell therapy and Protein product manufacturing, characterization, storage, and distribution
3. Regulatory consultation and support
4. Quality control
5. Quality assurance managed through an electronic Quality Management System (QMS) with a dedicated staff of 16 people.