Today’s research projects frequently require multi-disciplinary facilities. Jelle Hanse, Cleanroom Modules, describes a building project that bridged the fields of biology and engineering
The worldwide need for the development of replacement human tissue, via regenerative medicine and stem cell applications, recently resulted in the commissioning of a state-of-the-art research facility at the University of Loughborough, in the UK. The now completed 770m² multi-disciplinary Centre for Biological Engineering combines cleanrooms and labs that will enable this important human cell and tissue research to be carried out.
The University aims to achieve the realisation of regenerative medicine, cell technologies and plasma medicine by combining the human cell and tissue research programmes of three of its departments: Chemical Engineering, the Wolfson School of Mechanical & Manufacturing Engineering and Electronics & Electrical Engineering.
Flexibility and transparency in the design were key to the success of combining the three different fields into one multi-disciplinary research centre. The team at Clean Modules used their previous experience in designing and constructing cell and tissue cleanroom facilities and their novel System I modular cleanroom construction method to ensure that the facility is highly versatile and space-efficient, yet compliant with all the regulatory requirements.
The facility for Biological Engineering Research is a key area within the new Centre. Its range of labs for microbial, animal and human cell culture research will enable the staff to compete with biological engineers on a global scale.
To ensure the risk of exposure to biological agents is minimised, the laboratory research area has been built to Microbiology Containment Level II, in accordance with the 1995 EC Biological Agents Directive. An isolated air system, special room pressure regimes and strict staff operating policies ensure the safety of both the Centre’s staff and surroundings.
Also, within the new Centre, the Wolfson School of Mechanical & Manufacturing Engineering has a dedicated cGMP cleanroom suite that focuses on automated human cell culture, cell culture optimisation and mechanical stimulation of growing tissue. Designed to run to an EU GMP Classification Grade B standard, the facility includes cryogenic storage facilities as well as manual and automated cell culture areas, designed to run in an EU GMP Classification Grade A environment.
The facility will aseptically culture, expand, differentiate and harvest adherent cells to be used in the cGMP manufacture of clinical trial phases I to III and licensed product batches of somatic cell therapeutic medicinal products.
Approval from the UK Medicines and Healthcare Agency (MHRA) is essential for frontline medicine and healthcare product research; however, no MHRA reference guidelines were available for this type of research. Extensive discussions between the University, Clean Modules and the MHRA mapped out this new territory and ensured the cGMP facility was MHRA compliant.
The Centre also houses a bioelectrical engineering facility that integrates an advanced atmospheric gas plasma laboratory with a Class II cell laboratory so that engineers, physicists and life scientists can work together under the same roof. The facility represents the world-first integrated laboratory in plasma medicine with co-located plasma and cell labs.
Finally, the three departments will share a common autoclave, storage and office area that will support the research.
The Centre of Biological Engineering brings together three fields of study: biology, engineering and medicine. Each department contributes to the common goal; the realisation of regenerative medicine, cell technologies and plasma medicine for regeneration of human cell and tissue. The partnership between Clean Modules and the University of Loughborough has resulted in an exciting innovative new cleanroom and laboratory facility with immense potential for world-breaking developments in human cell and tissue regeneration.