Background

Leica Biosystems is a global leader in workflow solutions and automation for cancer diagnostics. Leica Newcastle employs over 300 people and develops and supplies diagnostic reagents to pathology laboratories throughout the UK.

The company attended the Newcastle Node’s launch event and over the last four years a relationship between the Node and Leica has developed into a highly successful collaboration. Through understanding Leica’s requirements, the Node saw first the need to develop an innovative Biobank with an industry focus that could supply high quality tissue samples with assured governance. Leica assisted with public engagement events attended by the Human Tissue Authority that were the prelude to establishment of the Cellular Pathology Biobank (CEPA). A pathway for supply of human tissue samples was thereby created providing an essential resource for product development and quality assurance. The benefits of the Leica collaboration have proved to be much greater than just sample supply, however. For Leica, there has been access to consultant pathologists and the Node facilities including TMA and biomarker expertise.

Funding

After an initial £140k of NIHR Research Capability Funding (RCF) for set up, the establishment of CEPA stimulated the Node to expand its biobanking activities and CEPA has actively participated in the nationally important MRC funded biobanks: Quality in Organ Donation (QUOD; £80k) and Immune-mediated Inflammatory Disease (IMID). Further, the CEPA Biobank has attracted Innovate UK funding for tissue collection for advanced cell therapy manufacturing and from Achilles for a ‘first in man’ clinical trial of clonal neoantigen T cells (for melanoma and lung cancer). Recently, in partnership with the Newcastle In Vitro Diagnostics Co-operative (MIC), the Biobank attracted Innovate UK funding for development of point of care testing for stroke diagnosis (SAMPLE and POCKITT; £230k). Leica spend around £500k p.a. on tissue blocks from international tissue brokers and have indicated that they would prefer to procure these samples from the Node over time.

Purpose

To create new pathways for development and evaluation of diagnostics and novel therapies, through linking pathologists and trainees in Newcastle University and Healthcare Trust with Industry.

Main achievements / outcomes

• Established a new route for supply of high-quality human tissues taken with consent and validated by pathologists from the Node’s CEPA biobank to UK industrial concerns.
• Developed a costing model and contract with Leica Biosystems for ongoing tissue supply, replacing international ‘tissue brokers’ with a robust and ethically sound process that ensures optimal quality assurance for diagnostic reagents to global customers.
• Building on the successful relationship with Leica, the CEPA biobank has expanded to a staff of four and is developing a portfolio of industrial customers requiring a range of sample types.
• Expanding the Leica collaboration from just tissue procurement to active involvement of people, including pathologists who have provided ‘voice of customer’ advice, trainees and clinical researchers. The proximity of Leica to the Newcastle Node has enabled trainee placements and an outstanding young Leica trainee is completing an MSc through the Node.
• Establishment of Biobanking pathways in the Trust enabling targeted collection of tissues for advanced cell therapies with support from Innovate UK and Pharma.

Future direction

CEPA aims to grow and develop a supply chain from the 7 NHS Trusts in the North East. It plans to become a major supplier for Tissue Solutions and the Medicines Catapult, as well as the national Centre for Photonics Industry. CEPA aspires to develop a portfolio of SME and research customers and play an increasing role in the collection and processing of human tissues for advanced cell therapies.

Note: CePA is now the NovoPath Biobank and the MRC Node is now NovoPath, The Newcastle MRC Node.