Since its creation in 2002, Biovault has set out to be the most trusted, experienced and fully accredited partner for organisations looking to outsource human tissue processing and storage. As part of this we actively seek relevant accreditations both here in the UK and further afield to ensure we overtly operate at the very highest standards.
Human Tissue Authority (HTA) – Biovault holds an open-ended, unconditional licence from the HTA that authorises us to process and store all transplantable material for human application. The aim of the HTA is to support public confidence by licensing the organisations that store and use human tissue and we fully support this goal. Biovault is very proud that it has never had any conditions placed on its licence. [Licence no: 11063, last routine inspection being in March 2012]
JACIE – Biovault has recently gained accreditation from JACIE, the Joint Accreditation Committee for the two leading scientific organisations involved with blood and bone marrow-derived stem cells transplantation in Europe. Biovault supports its aims of promoting high-quality patient care and laboratory performance in the field of haematopoietic stem cell collection, processing and transplantation.
As of May 2012 there are only 119 centres JACIE accredited in 19 countries and we are proud to be one of them!
ISO 9001 Standard – Maintaining the very best quality management processes is a critical part of our work and Biovault has earned the internationally recognised accreditation for its quality management process. In addition to ensuring that quality management processes meet regulatory standards, ISO 9001 also encourages continual improvement of these processes, something Biovault takes very seriously. The ISO 9001 Standard is issued by the International Organisation for Standardisation, which governs the standards for business and government in 162 countries. [ISO 9001:2008 Certificate no: GB04/62552]
ISO 13485 Standard – This Standard ensures a comprehensive management system for the design and manufacture of medical devices. [Certificate no: GB07/72849 – for example, CE-marked Cord Blood Collection Kits].
Human Fertilisation Embryology Authority (HEFA) – In late 2011, Biovault applied for accreditation from the UK’s independent regulator that oversees the use of gametes and embryos in fertility treatment and research.
Food and Drug Administration (FDA) – Biovault is currently applying to the U.S. Food and Drug Administration for approval of a clinical trial involving human stem cells.
Biovault also works with the following bodies:
Biovault has been issued the Certificate of Registration for the Community Trade Mark by The Office of Harmonisation for the Internal Market (OHIM). OHIM is the official trademarks and designs office of the European Union and its certificates are valid in all 27 EU countries.
National External Quality Assessment Service (NEQAS)
Biovault ‘s flow cytometers are externally quality controlled by NEQAS, which has been providing a comprehensive worldwide laboratory assessment service since 1969. A network of 144 schemes operating from 24 centres at major hospitals, research institutions and universities, NEQAS’ aim is to enable laboratories to fulfil quality goals and facilitate optimal patient care.
Tissue Banking Associations
We are active members of the following associations:
- British Association for Tissue Banking (BATB)
- European, Middle Eastern & African Society for Biopreservation and Biobanking (ESBB)
- International Society for Biological and Environmental Repositories (ISBER).
~~ Biovault has a worldwide patent for its processing technique for controlling the concentration of its stem cell products to match the specific requirements of the therapy for which they are being produced ~~