Gates Biomanufacturing Facility (GBF) supports clients by leveraging cutting-edge biologics analytical development technologies and best-in-class talent to establish reproducible, scalable, and phase I compliant processes that can change the future of patient care. Having biologics development services, analytical, manufacturing, logistics, quality, and regulatory under one roof allows us to plan, troubleshoot, and make decisions in a timely manner.
Whether you have an established process or need to develop an entire process, GBF is here to help. We work on various types of molecules, including:
- Recombinant proteins
- mRNAs
- Plasmids
- Nanoparticles
Biologics Process and Analytical Development
GBF’s Biologics team specializes in producing challenging proteins. Our team has expertise in protein refolding and formulation to ensure development of a purified, folded, functional, and stable protein formulation. We offer end-to-end biologics process development services:
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- Microbial fermentation
- Cell line development
- Purification development
- Chromatography optimization
- Protein refolding
- Tangential flow filtration
- Formulation development
Our Biologics Analytical Development and Process Development teams work closely with QC to ensure critical quality attributes are defined and accurately measured using tools common to the industry:
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- Dynamic light scattering (DLS)
- Agarose/SDS-PAGE
- High-performance liquid chromatography (HPLC)
- Size-exclusion chromatography with multi-angle static light scattering (SEC-MALS)
- Ultraviolet-visible (UV-VIS) spectroscopy
- Host cell impurities (endotoxin, HCPs, DNA)
- Enzyme-linked immunosorbent assay (ELISA)
- Cell-based assays
We apply phase-appropriate Good Laboratory Practices (GLPs) and Good Documentation Practices (GDPs), emphasizing process control and patient safety. Our state-of-the-art facility and fully trained staff are committed to support biologics innovation, from bench to bedside.
Scale & Accelerate Your Biological Therapies
Our Biologics Process Development labs are comparably equipped to both our GMP suites and the QC laboratory to ensure a seamless transition to Phase I compliant production and maintain critical quality attributes throughout development. Bench to GMP scale Fermenters, coupled with Chromatography and Tangential flow filtration systems, provide a proven development system that scales in a predictable manner.
Benefits of Outsourcing Biologics Process Development to GBF
Working with GBF provides access to our best-in-class team, recruited from start-ups, biologics and pharmaceutical CDMOs’ around the county. We are happy to discuss our established processes and bring in the new equipment needed to manufacture your product. This gives GBF the knowledge, flexibility, and experience to adapt and overcome the expected and unexpected challenges that accompany early-phase biologics development.
With ties to the University of Colorado Anschutz Medical Campus and affiliated hospitals, GBF not only gives you access to leading experts in the field of biologics, 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.