Cleanroom bridges biology and engineering

Paul Boughton
The world-wide need for the development of replacement human tissue, via regenerative medicine and stem cell applications, has resulted in the development of a new state-of-the-arts cleanroom and laboratory research facility at Loughborough University in the UK.

The new 770 m² multi-disciplinary Centre for Biological Engineering is the latest investment in research to improve human health by Loughborough University and the East Midlands Development Agency.

The university aims to achieve the realisation of regenerative medicine, cell technologies and plasma medicine, through combining the human cell and tissue research programmes of three university departments; the Department of Chemical Engineering, the Wolfson School of Mechanical & Manufacturing Engineering and the Department of Electronics & Electrical Engineering.

To combine the three different fields of research in one multi-disciplinary research centre, flexibility and transparency were key to the design. The team at Clean Modules Ltd used their previous experience with 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 complies with all the regulatory requirements.
The Centre of Biological Engineering Research Area is one of the key areas in the new Centre of Biological Engineering. A range of laboratories for microbial, animal and human cell culture research will enable the centre’s staff to compete with biological engineers on a global scale.
Facilities associated with the Cell Technologies Group (Department of Chemical Engineering) include a range of new culture vessels (from 150ml spinner flasks to conventional 5L Stirred Tank Reactors), a Fluorescent Activated Cell Sorting (FACS) system, fluorescent microscopy and state-of-the-art analytical equipment all housed within a suite of Class II research laboratories. The aim of the work is to understand the interaction of the cell with the engineering environment for informed scale-up.
To ensure minimum risk of exposure to biological agents, 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.
Within the Centre of Biological Engineering, the Healthcare Engineering Group of the Wolfson School of Mechanical & Manufacturing Engineering has a dedicated cGMP cleanroom suite that focuses on optimised automated human cell culture. Designed to run to an EU GMP Classification Grade B standard, the facility includes cryogenic storage facilities, a manual cell culturing area and an area for automated cell culture containing an automated cell culture machine, designed to run in an EU GMP Classification Grade A environment.
The facility is intended to aseptically culture, expand, differentiate and harvest adherent cells to be used in the GMP/cGMP manufacture of clinical trial Phases I, II and III and licensed product batches of somatic cell therapeutic medicinal products. Products are anticipated to include cells and cell lines for allogeneic therapy and autologous cells for individual patients.
Approval from the Medicines and Healthcare products Regulatory Agency (MHRA) is essential for frontline medicine and healthcare product research; however no MHRA reference guidelines were available for this type of research work. Extensive discussions between the University, Clean Modules Ltd and the MHRA mapped out this new territory and the cGMP facility was designed to be MHRA compliant.
The Centre for Biological Engineering also houses the Plasma Medicine Group (Department of Electrical & Electronics Engineering) with extensive facilities in research into how gas plasmas and pulsed electric fields could preferentially control skin infection, accelerate wound healing, and suppress tumour growth.  This laboratory suite 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 laboratories.

Finally, the three departments will share common autoclave, storage and office areas 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 Ltd and the Loughborough University has resulted in a new exciting innovative cleanroom and laboratory facility with immense potential for world breaking developments in human cell and tissue regeneration.
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