Clean Modules has used its System I modular cleanroom construction method to help create a cleanroom and research facility at Loughborough University.
The new 770m multidisciplinary Centre for Biological Engineering was established to meet the need for the development of replacement human tissue via regenerative medicine and stem-cell applications.
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 and Manufacturing Engineering and the Department of Electronics and Electrical Engineering.
To combine the three different fields of research into one multidisciplinary research centre, flexibility and transparency were key to the design.
The team at Clean Modules 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 was versatile and space efficient, while still complying with all the regulatory requirements.
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 culture vessels (from 150ml spinner flasks to conventional 5-litre stirred tank reactors), a fluorescent activated cell sorting (FACS) system and fluorescent microscopy and 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 and 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.
Discussions between the university, Clean Modules 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 and Electronics Engineering) with 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 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 the realisation of regenerative medicine, cell technologies and plasma medicine for the regeneration of human cell and tissue.
