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Range of Services

Biovault offers services based on its operational status as a fully licensed Tissue Bank in the United Kingdom, having assisted other organisations worldwide and as a provider of Tissue Banking services to the National Health Service in the United Kingdom.

Specifically, Biovault was accredited by the Medical and Healthcare Regulatory Authority (MHRA) until that organisation’s responsibility for Human Tissue Banking passed to the UK Human Tissue Authority in 2006.

Biovault holds the following:

ISO 9001:2008

ISO 13485 (Medical Devices)

A full unconditional Human Tissue Authority Licence

Joint Accreditation Committee - International Society for Cellular Therapy (ISCT) & European Group for Blood and Marrow Transplantation (EMBT) (JACIE)

Biovault is currently actively applying for:

Human Fertilisation and Embryology Authority Licence.

Biovault’s expertise in Flow Cytometry is externally quality controlled by

UK National External Quality Assurance Service (UK NEQAS)

Consequently Biovault can provide a wide range of services, from consultancy support in planning tissue banking and transplant services, through the design and commissioning of a fully managed local tissue banking service to the specification, design build commissioning and training for a client-owned and operated facility.

The support services offered can provide assistance with all peripheral elements either directly through Biovault or indirectly through an associated consultancy GMP Ltd, a UK-based spin-off.

 

Direct support can be provided in the following areas:

 

Technical, Ethical, Regulatory, Best Practice, GMP, International tissue standards

As a licensed and accredited tissue bank serving the public sector in the UK and the private sector worldwide and having already supported the start-up of tissue banks outside the UK, Biovault is in the strongest position to provide assistance in the generation of national guidelines and regulations and the interpretation of international guidelines.

Tissue Transport

Compliant transport systems are an essential element of tissue preservation.  Having imported samples worldwide and exported tissue for over 1000 transplants, Biovault can provide or offer guidance on tissue transport systems and logistics.

Out-of- Region banking

Where national laws only allow tissue for private banking to be stored outside of the country of origin, where demand does warrant indigenous banking facilities or where there is an immediate need to bank tissue, Biovault can import tissue into the United Kingdom and process and store in its Plymouth facility.

Facility provision and Support

Biovault has experience and expertise in Design and Build, Commissioning and validation, Direct Management or ongoing Management Support, Tissue Banking Consultancy, Technical Training, Internal Auditing and can provide these services in any combination.  This allows the support to areas and organisations lacking the skills, time or direct resources to instigate complex banking Tissue Banking facilities, plus those who wish to outsource the requirement to proven providers.

Technical Intellectual Property transfer

As a fully operational, licensed tissue bank, Biovault has fully developed procedures and systems which can be transferred to third parties in various ways such as direct purchase agreement or under a licensing arrangement.

Associated clinical process Intellectual Property transfer

Biovault is closely associated with the current clinical applications for stored tissue and direct access to the clinicians and associated techniques.  As with technical intellectual property this knowledge can be transferred under similar arrangements and direct participation in clinical trials can be facilitated.

Internationally compliant records system

Fundamental to tissue banking is total traceability and this is served by a fully compliant record system which is exhaustive, robust and stable and which has access requirements to records over very long periods (for example, current EEC legislation requires records to be maintained for 30 years beyond the use or disposal of stored tissue.  Biovault has a fully developed system that can either be provided by secure access via the internet, requiring no major investment by the client, with payment on a per-donor record basis, or as a tailored version to be hosted on the client systems.

Compliant Quality Management Systems (QMS)

Another essential element of tissue banking is an established, practical, integrated QMS.  Biovault has developed a tailored, ISO compliant, internet–based QM System which can be hosted with the base framework maintained on behalf of a client organisation or which can be provided under licence and converted to run as an intranet system on client systems.

Accreditation support services (HTA, JACIE, NetCord, ISO, Good Manufacturing Practice)

On a consultancy basis, Biovault can pass on its experience in the successful achievement of these major milestones, providing a project lead, an interpretation function regarding the requirements of the accrediting or licensing body and advice on the scaling of resources needed for the preparation process for audit.

Biovault Technical Brochure

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