FUJIFILM Biotechnologies, a contract development and manufacturing organisation (CDMO) for biologics, vaccines, and advanced therapies, held a ribbon‑cutting ceremony to mark the opening of its new, 2,000‑square‑meter (m2) quality control (QC) laboratory at its Hillerød, Denmark, commercial‑scale manufacturing site.
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The expanded QC footprint will enable bioassay and virology operations to meet current and future customer demand and support the site’s planned expansion.
Designed for flexibility and future growth, the laboratory features modern 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 harmonisation and data integrity.
The ribbon‑cutting ceremony was attended by FUJIFILM Biotechnologies leadership and employees, as well as Mikio Mori, Ambassador of Japan to Denmark, Hillerød Municipality Mayor Christoffer Lorenzen, and Thomas Senderovitz, M.D., The Danish Association of the Pharmaceutical Industry (Lif).
FUJIFILM Biotechnologies doubled its Hillerød capacity in 2024 from 6 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 m2 building that also features enhanced 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 laboratory was completed in March 2026 and subsequently received approval from the Danish Medicines Agency (DKMA) following an on‑site inspection. Laboratory operations will begin in May 2026.
The new Hillerød QC laboratory is part of FUJIFILM Biotechnologies’ kojoX modular, connected network of manufacturing facilities, where harmonised equipment, layouts, methods, and digital systems are used to enable cross‑site workflows and consistent application of quality standards across regions.
“With the expansion of our Hillerød site in late 2024, the site doubled its size from 6 bioreactors to 12 x 20,000 L bioreactors. With the expansion, the complexity and types of QC testing increased significantly. 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.” said Christian Houborg, senior vice president, and Hillerød site head, FUJIFILM Biotechnologies.