Translation & Manufacturing

The UK Cell and Gene Therapy Catapult has reported annually on the growth of the UK sector since 2017 using a number of different indicators. Translational activity is captured through the number of ATMP clinical trials ongoing across the UK of which there were 154 reported in total in 2020 – a 20% increase since 2019. Approximately 15% of these trials involved sites in Scotland.

In addition, an overview of the UK cell and gene therapy GMP manufacturing footprint for the years 2017-2020 showed a 102% growth in three years. Overall, the sector has an extremely positive outlook with numerous planned expansion projects on the horizon. Particularly encouraging is the future capacity that will be brought online for commercial manufacture by Edinburgh-based RoslinCT, demonstrating the commercial realisation of the UK industry.

Further details of both translational & manufacturing activity in Scotland is given below.

Translation

Established infrastructure & GMP Translational expertise including Univ Edinburgh, Scottish National Blood Transfusion Service (SNBTS), clinical development company TC BioPharm and CDMOs Roslin Cell Therapy & Merck BioReliance
Strong reputation of academic translation & spin-out formation (Pheno Therapeutics, Cellinta, Resolution Therapeutics, Macomics)
Strong links to the Cell & Gene Therapy Catapult and the network of UK Advanced Therapy Treatment Centres (ATTCs) that includes the Northern Alliance ATTC (Glasgow-Edinburgh-Newcastle)

Manufacturing

Scotland has ~30% of total UK GMP cleanroom space and >85% of QC lab space

ATMP Products manufactured/developed In Scotland:

GMP Pluripotent Stem Cells
Gammadelta T cells
Synthetic promoters
Dendritic cells for breast cancer and Acute Myeloid Leukaemia
Anti-EBV cytotoxic T lymphocytes for Post Transplant
Lymphoproliferative Disease
Corneal epithelial stem cells for ocular surface disorders
CD133+ cells for liver cirrhosis
Endothelial progenitor cells for cell tracking studies
Macrophages for hepatic cirrhosis
Mesenchymal Stromal Cells in Islet Transplantation
Numerous under Roslin CT as CDMO

Focus on Pluripotent Stem Cells – Manufacturing & Differentiation Technologies:

Translation

Established infrastructure & GMP Translational expertise including Univ Edinburgh, Scottish National Blood Transfusion Service (SNBTS), clinical development company TC BioPharm and CDMOs Roslin Cell Therapy & Merck BioReliance
Strong reputation of academic translation & spin-out formation (Pheno Therapeutics, Cellinta, Resolution Therapeutics)
Strong links to the Cell & Gene Therapy Catapult and the network of UK Advanced Therapy Treatment Centres (ATTCs) that includes the Northern Alliance ATTC (Glasgow-Edinburgh- Newcastle)

Manufacturing

Roslin CT and SNBTS world leading in the production of GMP pluripotent stem cell banks (ES/iPS)
Roslin CT & SNBTS are 2 of only 3 GMP manufacturers of stem cell lines in UK
A cluster of over 30 companies involved in the whole supply chain including cell line supplies, screening, characterisation, GMP manufacturing, QA/ QC and a range of enabling and supporting technologies

Focus on Place – Established & Emerging Cluster Locations for Translation & Manufacture of ATMPs

Edinburgh BioQuarter

A leading global destination for healthcare delivery, groundbreaking medical research and life sciences innovation with ambitions to create Scotland’s £1 billion Health Innovation District.

The Centre for Regenerative Medicine (CRM) contains Translational laboratories and GMP manufacturing facilities – currently occupied by SNBTS and Roslin CT
The new 8,000m2, £50 million Centre for Tissue Repair adjacent to CRM is due to open in 2021 forming an Institute for Regeneration and Repair and housing ~250 additional researchers
BioQuarter is also home to the Edinburgh Royal Infirmary, the new The Royal Hospital for Sick Children & Department of Clinical Neurosciences, the Anne Rowling Regenerative Neurology Clinic, Edinburgh Imaging, Health Data & Bioinformatics Institutes, Edinburgh Clinical Research Facility and Building Nine – the Life Sciences Innovation Centre.

Heriot-Watt Research Park – Riccarton

An internationally recognised centre for high calibre science and engineering research, located at Riccarton Campus on the west side of Edinburgh. It is home the Jack Copland Centre – Headquarters of the Scottish National Blood Transfusion Service (SNBTS) – a new facility with world-leading expertise in blood, tissues, cells and advanced therapies manufacturing containing:

6 Grade B and C clean rooms (>350m 2 )
Large Grade D Blood and Tissue space (>1000m 2 )
MHRA approved GMP testing facilities for Flow, PCR, Biosafety Strategic objectives of the centre are to:
Improve supply chain management
Allow scale-out of manufacturing to support larger scale pivotal clinical trials and adoption of ATMPs
Facilitate the translation of more complex advanced therapeutics.
Support the introduction of new manufacturing techniques and intelligent production systems to improve quality, safety & efficiency.

Edinburgh BioCampus

BioCampus is a bio-manufacturing science park initiative that was instigated by Scottish Enterprise. It comprises serviced development land totalling around 12 ha (30 acres) at Easter Bush on the south side of Edinburgh, upon which a 2,500 sq m (27,000 sq ft) building suitable for cGMP bio-manufacturing was erected in 2001. The location benefits from being close to the research expertise of the Roslin Institute, the Roslin Innovation Centre (home to ATMP technology companies such as AskBio (Bayer), Censo Technologies, Cytochroma and Ingenza) and Pentland Science Park where vaccine specialists GalvMed and the Moredun Research Institute are located.

Translation & Manufacturing

Translation

Manufacturing