Loughborough University

Technical Specification:

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 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.

The Centre of Biological Engineering Research Area is one of the key areas in the new facility. 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. 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 the surroundings.

Designed to run to an EU GMP Grade B standard, the automated cell culture 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 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 and the MHRA mapped out this new territory and the cGMP facility was designed to be MHRA compliant.

The Bioelectrical Engineering area is used for research into how gas plasmas and pulsed electric fields could preferentially control skin infection, accelerate wound healing and suppress tumour growth. The 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's first integrated laboratory in plasma medicine with co-located plasma and cell laboratories.