FUJIFILM Biotechnologies Opens New Quality Control Lab in Denmark

FUJIFILM Biotechnologies, a CDMO for biologics, vaccines, and advanced therapies, opened its new, 2,000‑square‑meter (m2) quality control (QC) laboratory at its Hillerød, Denmark, commercial‑scale manufacturing site. The expanded QC footprint will enable bioassay and virology operations to meet current and future customer demand and support the site’s planned expansion.

The lab features modern ventilation systems, personnel and material airlocks, and an open‑plan layout designed to accommodate future growth. 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 lab also incorporates robotics and an ongoing LIMS implementation across the company’s global network of sites to enable digital harmonization and data integrity. 

Construction of the lab 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.

“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.” – Christian Houborg, Senior Vice President, and Hillerød Site Head, FUJIFILM Biotechnologies.