Quality Assurance (QA) and control is not only one of GBF’s priorities, but also one of our strengths. All aspects of the facility and operations are maintained according to phase 1 GMPs. Employee training, document control, equipment calibration and preventative maintenance are tracked in our electronic quality management system. We encourage customer audits as part of all new project onboarding.
Our Quality Control (QC) team performs release testing for all of our biologics and cell therapy cGMP products. Environmental monitoring for the entire CDMO facility is also performed in QC.”
Facility Capabilities
GBF operates a 20,000-square-foot GMP facility adjacent to the CU Anschutz Medical Campus. The site is compliant to ISO 7 GMP standards and operates FDA-compliant quality management systems (QMS). These quality control systems include:
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- Raw material vendor qualification following phase 1 cGMP
- GMP material inspection and quarantine processes
- Controls to ensure proper material storage and use before expiry
- Electronic document control system to ensure the most up-to-date documents are used
- Verification systems to review batch records and test standard operating procedures (SOPs)
- Close monitoring of the assay development process to facilitate assay qualification and transfer
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Quality Control & Testing
Our GMP facility is run by an experienced team of cell therapy experts, facilities engineers, and quality assurance specialists who ensure our quality systems are properly enforced and meet regulatory standards. Across the board, all Gates Biomanufacturing employees undergo extensive training to ensure that operators and personnel have the latest knowledge and competencies needed to develop high-quality, reproducible cell therapy development processes and cell therapy products.
Our operations are also overseen by a Regulatory Program Director whose job is to bridge our various departments and guarantee that life-cycle planning and compliance activities are up to standard and up to date based on the latest regulatory standards. Contact our team today to learn more!