FACILITY

EUFETS multi-purpose facility

EUFETS operates within a state-of-the-art facility providing a unique combination of GMP and BSL2 laboratories. 

Manufacturing is performed within thirteen separate cleanroom suites classified as class A/B (class 100 / ISO 5) and class C suites (class 10.000 / ISO 7) with a total cleanroom capacity of approximately 500 m². All suites are equipped with state-of-the-art equipment and are classified as BSL 2.

This multi-purpose facility enables simultaneous handling of a variety of products according to our customers' needs while avoiding cross-contamination and ensuring the highest quality standards. To cover all aspects from process development to product release, EUFETS has more than 600 m² of Process Development, and QC laboratories, fully controlled under our quality system.

All laboratories are BSL 2 classified and have been built to satisfy the stringent demands of the biotechnology and pharma industry.



EUFETS has facility equipment monitoring with automated alarm reporting, HVAC system and uninterrupted power supply for all critical equipment in the clean room and laboratories.

EUFETS also provides GMP cryo-storage capacity for the cryopreservation of cellular products in a 24/7 monitored cryofacility.

Facility Overview:

  • 3,500 m² overall premises
  • 500 m² cleanroom area (BSL1/2):
    Cleanrooms ISO 8 (C), ISO 7 (B), ISO 5 (A)
  • 600 m² development and QC laboratories (BSL1/2)
  • Cryofacility (24/7 monitored)
  • GMP certified since 1999

Cleanrooms

  • BSL2 classified
  • 6 suites ISO 7 (B)
  • 7 ISO 8 (C)
  • Separate flow of personnel, materials, and product
  • 24/7 security system and HVAC monitoring system
  • Irradiation of cellular product on site

Our cleanrooms are fully equipped with standard cell culture technologies, including cell enrichment and depletion systems, single-use bioreactors of different sizes, multistack manipulators, single use downstream processing systems for continuous flow centrifugation and tangential flow filtrationincubators, microscopes, centrifuges (bags and tubes), plasma extractors, scales and more. Irraditiation device for cellular products and controlled rate freezers are in close proximity of the cleanrooms.

Quality Control Laboratories

  • BSL1/2 classified
  • Segregated from cleanroom manufacturing area
  • Analytical methods for: identity, potency, purity and stability
  • In-process and release testing

EUFETS’ QC labs are fully equipped to perform optimal analytical methods to measure identity, stability, purity, safety and potency of our customers’ products. Areas for different analytical methods such as microbiology, molecular biology and cell biology are segregated.

In addition to standard lab equipment our QC lab is equipped with multiple flow cytometers, ELISA plate readers, QPCR and ddPCR systems, automated cell counters, blood composition analysers, metabolite analysers, automated sterility measurement devices, HPLC systems, fragment analysers, imagers and many more. 

Development Laboratories

  • BSL1/2 classified
  • Segregated from cleanroom manufacturing area
  • Flexible configuration  

EUFETS’ development labs are well equipped to support technology transfers, new process developments as well as the development of analytical methods. The labs are equipped for cell culture and molecular biology work and allow the handling of a variety of different product types such as cell products (primary cell, cell lines, naïve, differentiated or gene modified), viral vector products (producer cell lines and vector supernatants) and ivt mRNA products.

Our development areas are equipped with LAFs, incubators, bioreactors, microscopes, cell separation/enrichment devices, microscopes, centrifuges (bags and tubes), multiple flow cytometers, QPCR and ddPCR systems and many more.