Monday, November 29, 2010

Multi-Disciplinary Research Cleanroom Facility

Jelle Hanse
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-art cleanroom and laboratory research facility at Loughborough University.
The new 770m² 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 realization of regenerative medicine, cell technologies, and plasma medicine, through combining the human cell and tissue research programs 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 in one multi-disciplinary research center required flexibility and transparency in the design. The team used its previous experience with designing and constructing cell and tissue cleanroom facilities, and its modular cleanroom construction method, to ensure that the facility was highly versatile and space-efficient, yet complied with all the regulatory requirements. The result is a superb, advanced new facility featuring the latest equipment that the customer is delighted with and is proud to show to other research institutes throughout the United Kingdom and abroad.
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The Centre for Biological Engineering Research Area is one of the key areas in the new Centre for Biological Engineering. A range of laboratories for microbial, animal, and human cell culture research will enable the center’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 stateof- 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 Center’s staff and the surroundings.
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Within the Centre for Biological Engineering, the Healthcare Engineering Group of the Wolfson School of Mechanical and Manufacturing Engineering has a dedicated cGMP cleanroom suite that focuses on optimized 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 team mapped out this new territory and the cGMP facility was designed to be MHRA compliant.
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The Centre for Biological Engineering also houses the Plasma Medicine Group (Department of Electrical and 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 tumor 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 worlds-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 for Biological Engineering brings together three fields of study: Biology, Engineering, and Medicine. Each department contributes to the common goal; the realization of regenerative medicine, cell technologies, and plasma medicine for regeneration of human cell and tissue. The partnership has resulted in a new, exciting innovative cleanroom and laboratory facility with immense potential for world breaking developments in human cell and tissue regeneration.
Jelle Hanse is the Export Executive at Clean Modules Ltd, responsible for sales, marketing, and business development of Clean Modules Ltd on the international market. Jelle and the team at Clean Modules Ltd specialize in the design and build of cleanrooms, laboratories, and associated clean environments, especially using pre-built and modular construction for use worldwide. While covering all industries, Clean Modules Ltd has particular specialist knowledge of the Life Sciences, Healthcare, Pharmaceutical, Biotechnical, and related industries

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