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Oct 14

Cell manufacturing: standardising the future of medicine

Today, on World Standards Day, we consider the need for standardisation in regenerative and personalised medicine to support healthcare developments and ensure the future of medicine arrives early.

m-tissue-cell-biology-culture-flasks-istock_000006300680mediumCell therapies, where living cells are transplanted into a patient, have significant potential to treat and change the course of diseases currently unaffected by existing medicines.

Cell therapies are being investigated for health issues such as prostate cancer, stroke, paralysis, loss of eyesight, Alzheimer’s and diabetes and the market is expected to grow to £5-10 billion by 2025. The UK is a world leader in this field and hundreds of millions of pounds are being invested in translating these therapies from a research environment into effective clinical applications, with the first cell-based therapies reaching clinical trials and the first products emerging onto the market.

Due to the complex and non-uniform nature of cell populations, developing standardised approaches for the bioprocessing of cells is crucial. This will ensure cell therapy products are comparable throughout the manufacturing process and maintain product quality and safety on any changes in manufacturing.

As the UK National Measurement Laboratory and Designated Institute for chemical and bio-measurement, LGC plays a significant role in the International Organization for Standardization (ISO) Technical Committee (TC 276 Biotechnology) that is developing best practice guides and standards for bioprocessing and cell characterisation, leading the UK Delegation.

These guides and standards will improve the quality control and hence safety of cell-based products. They will support a more rapid progression of cell based therapies to the market place and make the future of medicine a reality for patients.

worldstandardsday2016_poster_midres-222x300Standards for cell characterisation and bioprocessing

LGC is involved in developing the following standards:

ISO 20391-1: Biotechnology – Cell Counting – Part 1: General guidance on cell counting methods

ISO 20391-2: Biotechnology – Cell Counting – Part 2: Experimental design and statistical analysis to quantify counting method performance

ISO TS 20399-3: Raw materials control for bioprocessing – Part 3: Best practice guide for developers

Manufacturing standardisation publications

Comparability, manufacturing, characterisation and controls. White Paper (2016) Regen Med. 11(5)483-492. DOI:10.2217/rme-2016-0053

 

 

 

LGC, the UK National Measurement Laboratory and Designated Institute for chemical and bio-measurement

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