Gates Biomanufacturing Facility (GBF) is an end-to-end service provider that manufactures biologics reproducibly for IND-enabling toxicology studies and Phase 1 Clinical Trials. Our production services, which are compliant with current Good Manufacturing Practice (cGMP) guidelines, cover various types of molecules including:
- Recombinant proteins
- mRNAs
- Plasmids
- Nanoparticles
Biologics Process Development
We recognize the challenges of operating a multi-product/multi-use facility. Our space is designed to minimize cross-contamination between cell therapy manufacturing and biologics manufacturing. Facility controls include:
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- Separate air handling units
- Separate manufacturing suites
- Separate materials and personnel entrances into GMP areas
- Separate storage for final product (cell therapy) and BDS (biologics)
Regulatory Compliance
Biologics manufacturing takes place at our GMP facility, adjacent to the CU Anschutz Medical Campus. The site is fully compliant to the indicated ISO standards and houses GMP production suites, where a wide range of biologics are processed, as well as full quality control (QC) and quality assurance (QA) teams.
GBF’s quality assurance (QA) team oversees both biologics process development and manufacturing. The facility’s Quality Management System complies with FDA requirements and is designed to respond to clinical needs informed by risk-based scientific decision making. Our mission at GBF is always to maintain compliance with FDA requirements and respond appropriately to any regulatory changes to accelerate the delivery of cutting-edge biotherapeutics to patients.
Equipment
GBF’s two ISO 7 and four ISO 8 clean rooms house a variety of state-of-the-art equipment for biologics production:
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- Single-pass HEPA filtered air supplied by a dedicated air handling unit
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- 50-liter working volume fermenter w/ sterilization-in-place (SIP) and clean-in-place (CIP) skid
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- Electric-hydraulic microfluidizer
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- Three ISO 5 biological safety cabinets
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- GMP dishwasher and ultrasonicator
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- Two 50-liter and one 200 L magnetic mixers for large-scale solution preparation.
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- AKTA PILOT chromatography system: 0.2L to 2L column chromatography capability
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- Ultra-Filtration/Tangential-Flow Filtration- Sartoflow Alpha plus pre-sterilized single-use system
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 in biologics manufacturing. Our end-to-end services empower our customers to develop and validate industry-leading products, manufacture them under controlled, highly consistent parameters, and ultimately introduce new high-quality biologics to clinical settings.
Let’s partner together to get your early-phase biology into the clinic in a cost-effective and time-efficient manner. Contact us for more information.