The hard cell

Few areas of science prompt as much controversy as cell-based therapies - if only because stem-cell research falls into this category - but their potential seems extraordinary. For example, in theory, cells could be taken from a patient's immune system and manipulated to increase their effectiveness, and then re-introduced into the patient's system. If it works, cell-based therapies could play a major role in fighting everything from AIDS to cancer.

However, most of these therapies are still at the earliest stage and there remain significant obstacles to overcome. First and foremost, there has not been clear guidance of what regulation exists at all, if any, for businesses and academia hoping to commercialize any discoveries related to cell-based therapy. This is why the Department of Trade and Industry (DTI) commissioned BSI British Standards to develop PAS 83 Guidance on codes of practice, standardized methods and regulations for cell-based therapeutics - from basic research to clinical application.

"PAS 83 highlights any relevant legislation and guidance surrounding cell-based therapies including stem cells. There are some grey areas in the legislation which the PAS helps to clarify," says Simon Alcock, committee manager with BSI British Standards. "In Europe, products are currently classified as medical devices or as medicinal products, but no European Directives deal specifically with cell-based therapies. A new EU Directive for advanced therapy medicinal products including stem cell products is being drafted, but the UK industry needed guidance on best practice right now."

The guide has been produced to define and capture the key stages in a product lifecycle, from cell/tissue procurement through to commercialization and post-launch requirements.

"The UK is a favourable environment in which to do stem cell research and PAS 83 has had input from key stakeholders, including the UK regulators who are directly involved with the development of European Directives in this area," Alcock continues.

"There's a good base of academic research going on and PAS 83 helps them better understand how they can commercialize their products. At its heart, PAS 83 is promoting best practice in the industry and it is hoped that the PAS will help this important UK industry to grow," he says.

For more information, visit:
www.bsi-global.com/feb07pas83

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