spacer
home > ebr > winter 2009 > small scale biomanufacturing – the uk experience
PUBLICATIONS
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...


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
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.

spacer
Keith Williams
spacer
spacer
spacer
Angela Osborne
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

International Research Coalition Verifies Safe Surgical Access to the Central Core of the Human Cochlea for the Very First Time

SHEFFIELD, UK, 8 November 2022: An international team of surgeons and scientists has, for the first time, validated safe surgical access to the central core of the human cochlea in a study funded by Rinri Therapeutics, a biotechnology company developing regenerative cell therapies for sensorineural hearing loss (SNHL).
More info >>

White Papers

Pharmaceutical Companies: Outsourcing Combination Product Manufacturing

Phillips-Medisize

Combination products are therapeutics that combine two or more products (drug/device, biologics/device, biologics/drugs, or drug/device/biologics), regulated and sold as a single unit. Examples of combination products include drug-coated implantable devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement