Mammalian & Microbial Manufacturing Site
The Seattle campus has been producing biologics products for more than 35 years.
AGC Biologics operates multiple cGMP manufacturing lines and a variety of scales for mammalian and microbial biologics at our site. With a uni-flow design, the campus offers capacity and technological flexibility, including extensive single-use systems, while ensuring compliance with current ICH guidelines required for cGMP compliance. This location employs the latest fed-batch and perfusion manufacturing processes and serves as our center of excellence for global formulation services.
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Our in-depth fact sheet provides all the details you need on the complete capabilities and services of this campus and its abilities to support your next project.
DOWNLOAD NOWFlexible Mammalian Manufacturing
For GMP mammalian manufacturing, we have multiple lines with single-use and stainless steel capabilities, allowing us to tailor our equipment to each project’s needs.
- 9 x 2,000 L single-use bioreactors
- 3,000 L stainless steel bioreactors
- Dedicated expansion and harvest/capture suites
- Separate pre- and post- viral inactivation suites
- Ultrafiltration and diafiltration with manual and automated options
And through integrated partnerships, we can offer fill-finish in both the U.S. and the E.U., all under one contract.
State-of-the-Art Microbial Manufacturing
For GMP microbial manufacturing, our 1,500 L stainless-steel fermentation skid includes automated batch control, an 800 L media tank, and dedicated acid, base, and antifoam tanks. The suite also features centrifugation, homogenization, automated chromatography, in-suite protein analysis, 20,000 L of buffer storage, and ISO 6 areas for bulk filtration and fill.
Our capabilities also include:
- Experience across a wide range of host cells and molecule types
- Process expertise for insoluble inclusion bodies, secreted proteins, intracellular soluble proteins, and more
- Protein analytics (GMP), IPC, and release testing
Cell Line Development Expertise
We offer cell line development services covering new cell line creation, cloning, cell banking, and transfer to GMP manufacturing. By using proven technology and automated screening, we are able to rapidly generate stable, high-performing cell lines for a wide range of proteins. With decades of experience, we support programs involving mAbs, bispecific antibodies, ADCs, and other complex proteins.
Process Development & Optimization
We provide comprehensive development services, supporting projects from early laboratory development through to commercial production. Our expertise covers microbial and mammalian processes, including insect cell systems, and includes reliable transfer, verification, and optimization of customer processes to ensure smooth progression across development stages.
Capability highlights:
- High-throughput systems, including the Ambr®250
- Bench and pilot plant bioreactors
- Chromatographic and tangential flow filtration (TFF) systems
Analytical & Formulation Development Leaders
Our team provides advanced analytical and formulation development services backed by expertise in structural biology, analytical characterization, and cell-based bioassays across multiple reporter systems and cell lines. We also support extended characterization and comparability studies, with qualified chromatography and electrophoresis platforms designed to deliver reliable, decision-ready data.
Learn more about our global analytical and formulation services
Comprehensive Quality Control
We offer full QC services, including release testing as well as drug substance (DS) and drug product (DP) stability support, backed by thorough documentation, policies, and procedures. Our approach includes site-specific processes, specifications, and records tailored to program needs, while leveraging a global network of sites with decades of biologics expertise. This shared knowledge and best-practice approach helps ensure we meet both clinical and commercial requirements.
