BSI British Standards Publishes New Glossary To Help Promote The Safe And Efficient Commercialisation Of Regenerative Medicine Products In The UK

Main Category: Pharma Industry / Biotech Industry
Also Included In: Pharmacy / Pharmacist
Article Date: 16 May 2008 - 0:00 PDT

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BSI British Standards has published a Publicly Available Specification (PAS) which defines the terms commonly used in the field of regenerative medicine. PAS 84, Regenerative Medicine - Glossary, provides clear guidance on the meaning of terminology currently used in the UK by industry, regulators, government and academia. This will help the key stakeholders to communicate more effectively and allow the commercialization of the new technology to take place more efficiently and safely.

Developed in consultation with UK stakeholders, this document is intended to help:

- Facilitate a common understanding of the science of regenerative medicine
- Prepare for legal, commercial and societal issues
- Improve communication and understanding of the science of regenerative medicine
- Demonstrate best practice and product quality
- Reduce research, development, production and transaction costs.

PAS 84 contains over 200 definitions in the areas of cell and tissue components, non-cellular components, cell and tissue procurement, measurement and analysis, manufacturing and production and clinical trials. These include:

- Tissue bank: collection of characterized tissues for clinical utility
- Cell authenticity: degree to which a population of cells has the correct identity and is free of other cell types
- Safety: freedom from unacceptable risk.

PAS 84 follows the publication of PAS 83, Guidance on codes of practice, standardised methods and regulations for cell-based therapeutics in November 2006. This standard was written in response to the increased scrutiny of current standardization and regulations by researchers, manufacturers and the general public as cell-based therapeutics have moved nearer to commercialization. Both PAS 83 and PAS 84 are available for download, free of charge, from http://www.bsigroup.com/PAS83 and http://www.bsigroup.com/PAS84 respectively.

Mike Low, Director of BSI British Standards, said, "Regenerative medicine is a rapidly expanding area and it is vital that standards are put in place to facilitate developments in research, manufacturing and implementation. BSI British Standards will continue to develop standards in this field."

In response to rapid growth in the area of regenerative medicine, BSI British Standards has established a new committee, RGM/1 (Regenerative Medicine). Included in its remit, the committee will:

- Ensure the UK view is given due consideration within the European Union, and European and International standardization organizations
- Develop and support formal standards and other standardization documents in the area of regenerative medicine and to promote their use by industry and other potential users
- Ensure due consideration of the need for standards and standardization is given by UK regenerative networks and organisations, and to coordinate activities and actions in this area.

Dr Julian Braybrook, Head of Measurement R&D at LGC and chair of the newly established committee, said, "I am delighted to be working with BSI British Standards and a committee which captures such wide expertise to ensure that the UK is at the forefront of progress in regenerative medicine. The next few years promise exciting developments in this field and standardization will play a vital role."

BSI British Standards is currently looking for individuals to join this committee. If you have expertise in the field of regenerative medicine and are interested in contributing please contact Ben Sheridan on ben.sheridan@bsigroup.com or 020 8996 7751.

For further information on regenerative medicine or to download PAS 83 or PAS 84 please visit http://www.bsigroup.com

About BSI British Standards

BSI British Standards is the UK's National Standards Body, recognized globally for its independence, integrity and innovation in the production of standards and information products that promote and share best practice. BSI works with businesses, consumers and government to represent UK interests and to make sure that British, European and international standards are useful, relevant and authoritative. For further information please visit http://www.bsigroup.com/britishstandards

About BSI Group

BSI British Standards is part of BSI Group, a global independent business services organization that inspires confidence and delivers assurance to customers with standards-based solutions. Originating as the world's first national standards body, the Group has over 2,250 staff operating in over 100 countries through more than 50 global offices. The Group's key offerings are:

- The development and sale of private, national and international standards and supporting information
- Second and third-party management systems assessment and certification
- Product testing and certification of services and products
- Performance management software solutions
- Training services in support of standards implementation and business best practice.

For further information please visit http://www.bsigroup.com

About LGC

LGC is an international science-based company and market leader in analytical, forensic and diagnostic services and reference standards. A progressive and innovative enterprise, LGC operates in socially responsible fields underpinning the safety, health and security of the public and the regulation of industry, for UK government departments and blue chip clients.

LGC operates internationally through five divisions - LGC Forensics, Life & Food Sciences, Pharmaceutical & Chemical Services, LGC Standards and Research & Technology, which houses specialist laboratories for the delivery of contracts under the Department for Innovation, Universities and Skills (DIUS) and to serve its designated role as the UK's National Measurement Institute for chemical and bioanalysis.

Our methodology is extensively accredited to the international standard ISO 17025. Headquartered in Teddington, Middlesex, the LGC Group employs over 1100 staff in 21 laboratories and centres across Europe and in India. Privatised in 1996 and now majority-owned by funds managed by LGV Capital, LGC was founded over 150 years ago as the Laboratory of the Government Chemist - a statutory function maintained by LGC today.

http://www.lgc.co.uk