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.
What is the AABB?
AABB is the global leader in standards development, accreditation and implementation of quality systems in transfusion medicine and cellular treatments.
- Held since 2016
- Standards for cellular treatment services
- High quality standard met throughout all cord blood operations
Human Tissue Authority (HTA)
What is the HTA?
The HTA was 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 Government.
- Held since 2006 – the very first cord blood bank to receive an HTA licence!
- Regular inspections
- Standards met for: procurement, testing, processing, storage, distribution, import of samples, export of samples
British Standards Institutions (BSI)
What is the BSI?
BSI is the business standards company that helps organisations all over the world make excellence a habit.
- Held since 2010
- Certified for operating a Quality Management System ISO 9001:2015
- Covers 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
What is 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 its components) in accordance with the Blood Safety and Quality Regulations
Federal Office of Public Health (OFSP)
Who are the OFSP?
As part of the Federal Department of Home Affairs, the Federal Office of Public Health (FOPH) is responsible for public health in Switzerland.
- Held since 2013
- Authorised for importation, exportation and storage of cord blood stem cells
Good Distribution Practice for Medicinal Products (GDP)
What is the GDP?
Good distribution practice (GDP) is the standard that a medicines distributor must meet to ensure the quality and integrity of medicinal 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 of medicinal products
What is Swissmedic?
Swissmedic is the Swiss authority for the licensing and monitoring of cell products.
- Since 2013
- Regular audits
- Authorised storage facilities owned in Switzerland
- Standards met for import, export, processing, testing and long-term cryopreservation of stem cell samples
British Standards Institution Member
Who are BSI?
Established in 1901, BSI were the world’s first National Standards Body. Today, they have 90 offices in 193 countries, helping 84,000 organisations make excellence a habit.
- Held since 2019
- Support our commitment to raising standards and improving performance
What is 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