Clinical Biomanufacturing & Cell Therapy Services

Cell Therapy GMP Manufacturing

Gates Biomanufacturing Facility (GBF) is an end-to-end service that manufactures cell therapy products reproducibly and at scale. Our production services, which are compliant with current Good Manufacturing Practice (cGMP) guidelines, cover various types of cell therapies, including CAR T cells, Natural killer cells (NK), and induced pluripotent stem cells (iPSCs), as well as allogeneic and autologous therapies.

GBF’s cell therapy manufacturing capability is supported by our cell therapy development services and close ties to the University of Colorado Anschutz Medical Campus, a leading academic healthcare ecosystem. This means our production technologies and processes are consistently informed by the latest medical advancements. This affiliation also helps us keep our overhead low, making GBF a cost-effective drug development partner.

Contact us for more information on why GBF can be trusted to manufacture your therapeutic.

Regulatory Compliance

Cell therapy manufacturing takes place at our GMP facility adjacent to the CU Anschutz Medical Campus. The site is fully compliant to ISO 7 GMP standards and houses GMP production suites, where a wide range of cell therapy products are processed, as well as a full quality control (QC) laboratory.

The facility’s Quality Systems follow FDA requirements and are designed to respond to clinical needs informed by risk-based scientific decision making. Our mission at GBF is to always maintain compliance with FDA requirements and respond appropriately to any regulatory changes in order to accelerate the delivery of cutting-edge advanced therapy medicinal products (ATMP s) to patients.

Quality Assurance


GBF’s GMP cell therapy production site is run by a best-in-class team, including highly experienced cell therapy experts, who ensure the development and production of high-quality, consistent products; facilities engineers who assure that all manufacturing processes are operating within specifications at all times; and a quality assurance (QA) team, which oversees both cell therapy development and manufacturing and manages an FDA-compliant quality system that ensures cell therapies meet regulatory standards.


These teams are overseen by our dedicated Regulatory Program Director, who works with and connects all departments to ensure life-cycle planning and compliance activities are always up to date.

Advanced technology

 

GBF’s five clean rooms house a variety of state-of-the-art equipment for producing autologous and allogenic cell therapies:

  • G-Rex cell culture flasks
  • Cell culture bags
  • Sepax™ cell processing system
  • CliniMACS Prodigy®
  • CliniMACS Plus®
  • Rotea™ Counterflow Centrifugation System, as well as other automated filtration systems
  • CliniMACS Plus®

Currently, GBF’s facility has an output of up to 70 L of cell production media, with the standard product release timeframe of seven days. In certain cases, however, we can deliver rapid product release for limited products. This accelerated manufacturing turnaround can be as rapid as 16 hours.

Genetic Manipulations

 

GBF has experience with multiple forms of
genetic manipulations:

  • Lentiviral vectors
  • Gamma-retroviral vectors
  • CRISPR
  • Direct nucleic acid transfer (transfection
    and electroporation)

Whether developing a new protocol or transferring-in an established protocol, GBF has policies and systems in place to perform genetic manipulations in a compliant manner, minimizing risk of cross-contamination and mix-ups.

A Partner in cGMP Production.

 

We emphasize building strong relationships with our partners and clients. We believe in full transparency and have dedicated project managers that keep our partners up to date and notified of any milestones, deviations, and
batch releases.

 

The unexpected is commonplace when manufacturing ATMPs for Phase 1. Our end-to-end cell therapy services empower our customers to develop and validate industry-leading products, manufacture them under controlled, highly consistent parameters, and ultimately introduce new high-quality cell therapies in clinical settings.

 

Let’s partner together to get your early-phase cell therapy into the clinic in a cost-effective and
time-efficient manner.