One of the world's most accredited stem cell banks
Future Health Biobank is one of the world’s most accredited stem cell banks. Regarded by its peers as the most innovative, highly considered centre of excellence for quality and service within the stem cell banking industry. Processes in both the UK and Swiss facilities are licensed and accredited to the highest level and operate to GMP standards.
Future Health Biobank’s UK laboratory is a Human Tissue Bank, licensed by the Human Tissue Authority (HTA) and authorised by the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK Department of Health.
The UK Department of Health was amongst the first government bodies in Europe to issue a specific Code of Practice to govern the activities of Human Tissue Banks, which includes Cord Blood Stem Cell Banks. The objective of this Code of Practice is to ensure that safe, reliable quality tissue is produced and supplied to the health service for treatment purposes and medical applications. It is the Gold Standard for stem cell bank operations.
Human Tissue Authority (HTA)
Who are the HTA?
The HTA were created by the UK Parliament as non-departmental public body of the Department of Health,
overseen by an Authority of lay and professional members appointed by the Goverment
- Held since 2006 – the very first cord blood bank to receive HTA licence!
- Regular inspections
- Standards met for: procurement, testing, processing, storage, distribution, import of samples, export of samples
British Standards Institution (BSI)
Who is the BSI?
BSI is the business standards company that helps organizations all over the world make excellence a habit.
- Held since 2010
- Certified for operating a Quality Management System ISO 9001:2015
- Cover procurement, storage, testing, processing, import, export, distribution and disposal of stem cells
- Certified across cord blood, cord tissue and dental pulp
Medicines and Healthcare Products Regulatory Agency
Who are the MHRA?
The Medicines and Healthcare products Regulatory Agency regulates medicines,
medical devices and blood components for transfusion in the UK.
- Held since 2005
- Regulated to hold a Blood Establishment Authorisation
- Store and distribute blood (and it’s components) in accordance with the Blood Safety and Quality Regulations
Federal Office of Public Health (OFSP)
Good Manufacturing Practice (GMP)
What is the GDP?
Good distribution practice (GDP) is the standard that a medicines distributor must meet to ensure the quality and integrity of medical products for human use.
Medicinal products for human use must be:
- Stored in the right conditions at all times, including during transportation
- Meet the requirements of the Guidelines on Good Distribution Practice of Medicinal Products for Huma Use (2013/C 343/01) of the European Commission
- Meet the requirements of the European GMP Part II (Basic Requirements for Active Substances used as Starting Materials) and GMP Part IV
- Held since 2013
- Certification of GDP compliance for storage, Import and export medicinal products
British Standards Institution Member
Who are Cyber Essentials?
Cyber Essentials is a Government-backed, industry supported scheme independently verified by a qualified assessor. The scheme focuses on the following five key areas:
- Boundary Firewalls and Internet Gateways
- Secure Configuration
- Access Control
- Malware Protection
- Patch Management