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8 February, 2022 - 11:15 By Tony Quested

Sawston cell and gene therapy hothouse on exponential growth curve

One of the world’s most capable facilities to advance cell and gene therapy innovation and manufacture personalised cancer cures is gathering momentum at the heart of the Cambridge BioMedTech cluster.

Chief Operating Officer Dr Mike Scott, who previously enjoyed 28 years with Cambridge University Hospitals, says the Sawston hothouse – run by Advent BioServices under a service contract for US-based Northwest Biotherapeutics which owns the long-term facility lease – is “on an exponential growth curve” less than a year after opening its doors.

Its various laboratories, GMP clean rooms, cold room storage – to cryostorage temperatures – and biobank are already being used to good effect by Advent on behalf of NW Bio and various external clients – and the partners haven’t even started any external marketing as yet.

Furthermore, Advent is only utilising a relatively modest percentage of the capacity that will eventually be developed to expand production and capability in a number of HealthTec specialisms from tailored cancer vaccines to a raft of personalised cancer treatments.

Advent and NW Bio, who are developing the facility were buoyed and are already exploiting the recent award of specialist manufacturing and tissue handling approvals that should boost demand and productivity. Approval was recently received from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a licence for manufacture of GMP (clinical grade) cell therapy products at the facility. 

The MHRA licence enables the manufacture of DCVax-L products to get underway at Sawston in addition to continuing at a smaller GMP (good manufacturing productivity) facility in London.

The licence also permits the import and GMP manufacture of other cell therapy products under the UK’s supply of unlicensed medicinal products (‘Specials’) regime and for clinical trials under the Investigational Medicinal Products (IMP) Programme. 

Scott says the Sawston hub is being developed in phases, both to optimise the timing of capital requirements and to enable each phase to be state of the art when developed, as manufacturing technologies are advancing significantly in the field of cell therapies.

The company has developed the £3.5 million Phase 1A, comprising around 4,400 sq ft of the overall 88,345 sq ft – demonstrating the enormous potential for production long-term. Around £1.35m of the Phase 1A cost was funded through a competitive loan from the Cambridgeshire and Peterborough Development Authority.

The transatlantic owners of the facility anticipate that Phase 1A alone will be able to manufacture DCVax-L products for 45-50 patients per month, or 450-500 patients per year – a significant increase from the current manufacturing capacity of four to six patients per month which, to date, has been taking place in a GMP clean room in London.

The MHRA licence followed approval by the UK’s Human Tissue Authority (HTA) last October which covers the collection, processing and storage of human tissue and cells for medical purposes.

As Business Weekly reported when NW announced the Cambridge opportunity the Maryland company is working on a cancer vaccine for Glioblastoma Multiforme, the most aggressive type of brain cancer, with Phase III data expected soon. 

The treatment has been described as a potential ‘major breakthrough’ in the treatment of Glioblastoma, following the publication of blinded interim results in the Journal of Translational Medicine. 

The dendritic cell-based cancer vaccine is a fully personalised immunotherapy treatment that mobilises the entire immune system to fight tumours. 

Whilst immunotherapy treatments have made significant progress in recent years for the treatment of blood cancers, their ability to treat solid tumours, which make up 80 per cent of all cancers, remains a challenge and breakthrough developments have been few and far between when it comes to Glioblastoma. This therapy has been in development for a long time and it is finally getting closer to reaching the people who can potentially benefit. 

Advent has already built headcount at Sawston to over 40 people and continues its talent spotting; it is tapping into the broader bio corridor – from London to Cambridge to Stevenage – for expertise. It is also leveraging a proven apprentice programme and has already recruited three capable young hopefuls to the ranks.

When the Sawston facility is fully built out and in full operation it is estimated that it will employ around 300 highly skilled personnel, including many who may be trained through the apprenticeships programme.

To maximise overall potential capacity of the Sawston facility, Advent is actively recruiting third party clients interested in production of bespoke and personalised cell therapy products. The capacity for production of other products will also be an important resource for the region, helping to fulfil NWBio’s commitments to the Cambridgeshire and Peterborough Development Authority. Sawston can also store human tissue samples and cells for external enterprises and is in discussion with  local and national companies about this capability.

Scott has identified from dialogue with and intel gleaned from major players in the Bio industry that there is huge and growing international demand for exactly the type and variety of facilities Advent and NW Bio can supply – over and above the manufacture of their own product portfolio. 

“It is clearly a very good space for us to be in as market demand accelerates globally,” Scott remarks. “It is an exciting time for Advent BioServices and NW Bio and validates the decision to build and expand the Sawston facility.”

• Picture courtesy – Advent BioServices

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