Interest in stem cell storage is growing. Cleanroom Technology takes a look at one of Europe’s advanced processing and storage facilities, run by Smart Cells International.
Since the first stem cell transplant in 1988 much attention has focused on stem cell storage and potential stem cell therapy applications. Funding for stem cell research has increased dramatically as confidence in the potential clinical benefits of stem cell therapy grows.
Stem cells, given the right stimuli, are capable of transforming into other cells types found in the human body, such as liver, skin or red blood cells. Some stem cells are more “plastic” than others and can be used to replace damaged or abnormal blood cells as part of the treatment of some malignant blood disorders, such as leukaemia, as an alternative to bone marrow transplantation.
Umbilical cord blood stem cells are one of the most “naïve” types of cells in the body. Created during the earliest phases of development they have the potential to become specialised cells such as red or white blood cells. It is these properties, and the fact that the umbilical cord is a rich source of stem cells, that has prompted private companies to offer frozen storage of these cells from umbilical cord blood collected at birth.
There are specialised stem cell storage centres all around the country. Smart Cells International (SCI) is one of the UK’s longest-established stem cell collection and storage organisations, formed in February 2001. The company collects units of cord blood on behalf of families worldwide and stores them at its labs in West Drayton near London Heathrow Airport.
Following rigorous testing, the purpose-built processing and storage facility was opened in March 2009. The stem cells have now started arriving directly from donors and families in the UK and Europe.
Dr Peter Hollands, a director of SCI and senior lecturer in biosciences at the University of Westminster, says: “The new laboratories are as advanced as medical technology allows, and located such that they become a facility available to families not just in the UK, but around the world because of our proximity to London Heathrow Airport. “This can make a significant difference to collection and storage timelines,” he adds.
When the cord blood arrives at the laboratory, it is analysed to determine the quantity of blood and the number of cells it contains. The processing procedure separates and removes the red blood cells and the plasma thus reducing the volume of the stored unit.
All cord blood units are stored in the vapour phase of liquid nitrogen, in vessels located in a secure environment that is continually monitored and alarm protected. All procedures are undertaken in a sterile, controlled environment by specially trained staff. Jane Hughes is the recently appointed operations manager for the facility. She has had experience of similar cleamrooms, having been in charge of one for a medical school, and another facility involved prostrate cancer research.
Prior to 2004, all stem cell laboratories were able to apply for accreditation from the MHRA to ensure compliance with ISO 9000 standards, good clinical manufacturing and laboratory practices. But by the end of 2006 all laboratories that store human cells and tissues had be licensed by the Human Tissue Authority (HTA). SCI is fully licensed by the HTA and holds licence no 22522. SCI’s new Good Manufacturing Practice (GMP) facility thus complies with the standards used in pharmaceutical manufacture for environmental conditions and robust reproducible processes.
The new facility was installed within a standard commercial building within a business estate area, but provides standards that may be expected within a hospital environment. Designed, installed, project managed and commissioned by Clean Modules Ltd, the suite comprises a Grade B (ISO Class 5) process cleanroom with two biological safety cabinets, an unclassified QA lab, a Grade D (ISO Class 8) preparation room and Grade D cryogenic storage rooms with five liquid N2 vessels and two cryogenic freezers. The cryogenic storage room has been fitted with a low O2 monitor with alarms, to monitor oxygen depletion (e.g. due to liquid nitrogen spillage), with consequential risk to life.
In line with EU GMP regulations, the facility is fitted with an advanced Facility Monitoring System (FMS) for automated environmental monitoring of the cleanroom facility and the equipment feed data on air pressure, air particle count and liquid nitrogen level in the tanks back to a central dedicated computer that displays facility status room by room.
The facility has also been fitted with an Uninterrupted Power Supply system, which will maintain energy levels for at least two hours in the case of a power failure, ensuring that on-going works can be completed before loosing cleanroom conditions.
Clean Modules specialises in the design, construction and project management of modular, mobile or in-situ cleanrooms and has experience in this type of facility, having previously completed a cord blood cleanroom centre for the Anthony Nolan Trust, as well as an IVF stem cell bank at the Royal Hallamshire Hospital for the NHS and University of Sheffield, and a stem cell bank for the National Institute of Biological Standards and Control in Hertfordshire.
At West Drayton, the Grade B Process room houses two Sepax machines – automated processing systems for separating out the plasma and red blood cells from the cord blood – made in Switzerland by Biosafe. The systems require no additional equipment, such as a separated centrifuge, nor operator intervention during the separation procedure – this significantly reduces risk of cross-contamination and operator error.
The separation of stem cells from other blood components is achieved in a central core that spins the blood at high speed and through an optical reader, squeezes the separated components into the various compartments until the process is complete.
Contact Smart Cells International Ltd 56-58 Bloomsbury Street London WC1B 3QT UK T +44 20 7436 9966 F +44 20 7436 9977 .(JavaScript must be enabled to view this email address) www.smartcells.com
Clean Modules Ltd T +44 1332 696970 .(JavaScript must be enabled to view this email address)
Biosafe SA T +41 22 365 27 27 www.biosafe.ch