Mammalian & Microbial Manufacturing in Europe
Our AGC Biologics Copenhagen site is one of the largest and most active facilities in our global network. The core teams of scientists have decades of expertise in development and manufacturing, including eight commercial products brought to market. This means your product is being managed by some of the best in the business.
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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 ability to support your next project.
DOWNLOAD NOWSingle-Use Mammalian Manufacturing Powerhouse
Our mammalian manufacturing offers single-use bioreactors from 500 L to 2,000 L, with scales up to 12,000 L via our modular multi-pack capabilities. Additionally, our multiple independent mammalian lines utilize the latest fed-batch and perfusion manufacturing processes.
- 14 x 2,000 L single-use bioreactors
- 3 x 500 L single-use 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 E.U. and the U.S., all under one contract.
Microbial Manufacturing Expertise
Our GMP microbial manufacturing features up to 1,500 L working volume using stainless steel microbial fermenters and 2,200 L vessel volume, with extensive cGMP manufacturing experience, from E. coli to yeasts.
Our capabilities also include:
- 2 x 1,500 L stainless steel fermenters
- Experience across a wide range of host cells and molecule types
- Process expertise for insoluble inclusion bodies, secreted proteins, intracellular soluble proteins, and more
- Dedicated downstream and cell expansion suites
- Protein analytics (GMP), IPC, and release testing
Cell Line Development and Cell Banking
We offer cell line development services covering new cell line creation, cloning, transfer to GMP manufacturing, and mammalian cell banking. Using proven technology and automated screening, we can rapidly generate stable, high-performing cell lines for a wide range of proteins, helping you shorten timelines to IND and achieve higher titers.
Process Development & Optimization
We provide full development services, from lab development to commercial production including process transfer, cell line development, upstream and downstream development, process characterization, validation, and optimization of customer processes to ensure smooth progression across development stages.
Capability highlights:
- High-throughput systems, including the Ambr®250
- Bench-scale development and production, using high-throughput systems and pilot plant bioreactors
- Chromatographic and tangential flow filtration (TFF) systems
Robust Analytical and Formulation Development
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
End-to-End Quality Control
We offer full QC services and regulatory support, including release testing and stability support for drug substances (DS) and drug products (DP). All of our sites collaborate under our globally aligned quality system and are backed by thorough documentation, policies, and procedures. Our approach includes site-specific processes, specifications, and records tailored to program needs.
Committed to Sustainability
Our Copenhagen campus has a strong focus on sustainability and has achieved a Silver EcoVadis Sustainability Rating for being in the top 15% of companies assessed.
This site has also published ESG figures in response to evolving regulations and growing customer demand for transparency. This report provides a more comprehensive view of our sustainability performance, following a CSRD-compliant structure and including key disclosure requirements. It marks an important first step in our commitment to sustainable practices and transparent reporting.
