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Expanding Capacity to Support the Future of Viral Clearance Testing
Biologics Testing Facility in Cologne, Germany
As biologics and advanced therapies continue to accelerate, the demand for high‑quality viral clearance studies has never been greater. To meet that need, Charles River's Cologne, Germany facility - already a central hub for global viral safety and clearance testing - is entering an exciting new phase of expansion.
Beginning in Q2 2026, the site will add 200 square meters of new laboratory space dedicated to viral clearance studies. Purpose‑built for today's evolving safety requirements, the expanded area will operate under BSL‑3** conditions for handling biological agents, including HIV, and is fully qualified for BSL‑2 operations involving GMOs.
The new footprint features two independent, suite‑style laboratory units, each equipped with the full instrumentation and infrastructure required for viral clearance work:
- Suite 1: Three laboratory rooms
- Suite 2: Two laboratory rooms
Each suite includes its own dedicated entry lock, ensuring strict biosafety, optimized workflows, and robust separation between study activities. A central service room - housing the autoclave, storage, and support functions - connects the two suites, while the entire new laboratory section is structurally separated from the existing lab tract.
This expansion reflects our commitment to scaling capacity ahead of industry need - supporting innovative manufacturing platforms, advancing viral safety programs, and enabling clients to move their biologics confidently toward the clinic and beyond.
Viral Clearance: Advancements in Virus Production and Purification to Address ICHQ5A Updates
Updates to the ICH Q5A guidelines are generating new interest in virus titer and purity in viral clearance studies. Hear our experts share insights into new methods and developments in the production process of viruses you can use in your studies.
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