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home > ebr > winter 2009 > small scale biomanufacturing – the uk experience
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European Biopharmaceutical Review

Small Scale Biomanufacturing – The UK Experience

The adoption of the EU Clinical Trials Directive and the Human Tissues Act into UK law in 2004 has meant that NHS and academic research workers have to comply with increased regulatory standards in the production of advanced biotherapeutics for early phase clinical trials (1,2). For those advanced therapies designated as medicinal products (such as gene therapies and DNA vaccines), the principles of good manufacturing practice (GMP) apply, and these are inspected by the Medicines and Healthcare Regulatory Agency (MHRA). For those human cell- and tissue-derived therapies which are not classified as medicinal products, similar standards apply but the inspecting authority is the Human Tissue Authority (HTA). This has involved a significant investment by a number of academic and NHS centres in small scale biomanufacturing infrastructure to meet the regulatory requirements of the MHRA and the HTA.

In addition, research within the NHS in the regenerative medicine area is increasingly bringing forward new person-specific therapies for early phase clinical trials, with the requirement for more and higher throughput facilities to satisfy the demand. Recently, UK delegates working in this area met to discuss their experiences and approaches to addressing many of the...


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Keith Williams has been employed as the Clinical Biotechnology Centre’s Business Development Manager since 2007. In this role he has responsibility for identifying new product areas and collaborations with other academic institutions, ensuring that all pre-clinical and regulatory requirements have been met prior to technology transfer for GMP manufacture. Prior to this Keith was the CBC’s Operations Manager for seven years. Initially trained as Medical Biochemist, Keith worked for seven years for the NHS in Clinical Chemistry; followed by 14 years’ experience in biotechnology R&D, product validation, and technical support in industry, before returning to the NHS and joining CBC. Keith has combined experience of R&D, project management and operating in GMP and ISO 9000 environments, and has been exposed to some of the major regulatory bodies, including the MHRA and the FDA.

Angela is the Managing Director of eXmoor pharma concepts, a technical consultancy providing biomanufacturing process and facility design, GMP compliance and business planning. She trained as a biochemical engineer at UCL, and then joined British Biotech, where she worked on the development, scale up and early production of GMP material for clinical trials. Later at John Brown (which became Kvaerner), a multinational facility and process design company, Angela developed the pharmaceutical division of the company. At eXmoor pharma, she has worked with many of the major biopharmaceutical companies in Europe. Recent experience with smaller scale biomanufacturing facilities includes the National Biomanufacturing Centre in Speke, Cancer Research UK and GMP regenerative medicine facilities within three hospitals.

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Keith Williams
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Angela Osborne
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