Fujifilm Biotechnologies, a CDMO, celebrated the opening of its new, 2,000‑square‑meter quality control (QC) laboratory at its Hillerød, Denmark, commercial‑scale manufacturing site. The expanded QC footprint will enable bioassay and virology operations and support the site’s planned expansion, according to the company.

The laboratory features ventilation systems, personnel, and material airlocks, and an open‑plan layout. The space supports approximately 100 quality team members to conduct viral safety testing for drug substance/product release, scale capacity for complex cell‑based potency and ELISA methods, and perform raw material and critical total organic carbon cleanability studies to accelerate future partner campaigns.

The QC laboratory also incorporates robotics and an ongoing LIMS implementation across the company’s global network of sites to enable digital harmonization and data integrity.

The company doubled its Hillerød capacity in 2024 from six to 12 x 20,000 L mammalian cell culture bioreactors, increasing the complexity and volume for QC testing. The expanded production scale required expanded QC capabilities and advanced analytical equipment to support current operations and anticipated future demand. The QC lab is housed within a new 7,600-square-meter building that also features employee amenities, office and collaboration space, utility services, and an emergency generator to ensure uninterrupted operations and timely delivery of critical test results.

Construction of the lab was completed in last month and subsequently received approval from the Danish Medicines Agency (DKMA) following an on‑site inspection. Laboratory operations will begin in May 2026.

The new QC laboratory is part of Fujifilm Biotechnologies’ kojoX modular, connected network of manufacturing facilities, where harmonized equipment, layouts, methods, and digital systems are used to enable cross‑site workflows and consistent application of quality standards across regions, explains Christian Houborg, senior vice president and Hillerød site lead.

“Today, we are opening a world-class GMP-approved QC laboratory to elevate our quality control and be ready for the upcoming expansion, thereby continuing to manufacture advanced biological treatments for patients with severe diseases, such as cancer and rare autoimmune diseases. Together, we’re making a measurable impact for patients and partners around the world,” he said.

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