UK unveils national CMO to support biotech industry

Related tags Biotechnology Uk

In the UK, a groundbreaking partnership between government and
industry has led to the creation of a National Biomanufacturing
Centre, designed to make it easier for fledgling biotechnology
companies to get access to contract manufacturing for preclinical
and clinical projects.

The centre, run by UK company Eden Biodesign, is one pillar of the UK government's strategy of supporting the country's biotechnology industry, which is the largest in Europe with revenues of over £3 billion, second only in size to the US. The country contains about 400 biotechnology businesses, which provide jobs for more than 25,000 people.

However, with the big fish falling into foreign hands - what with Amersham's recent merger with General Electric, PowderJect's takeover by Chiron and Celltech soon to become part of UCB - the UK industry is now comprised largely of minnows such as Acambis, Antisoma, Vernalis and Xenova.

The new facility is designed to make it easier for the smaller players to take their projects through the clinic and onto the market, and hopefully generate a new crop of biotech 'majors' in the UK industry.

The company's business development director, Derek Ellison, told​ that this is believed to be the first project of its kind in Europe, and perhaps even the world.

"Small biotechnology companies often face a chicken-and-egg situation; venture capitalists like to have some proof that the concept they are peddling is valid before they will invest, but the companies often do not have the funds to conduct the early-stage clinical trials that are required to demonstrate proof-of-concept,"​ he said.

With the cost of these trials typically set at between £150,000 and £500,000, access to a facility such as the NBC allows companies to take these first steps, and could help support the UK and indeed broader European biotechnology sector, which for the first time actually shrank in 2003, according to a recently published report from Ernst & Young.

And the need for the NBC becomes more apparent, said Ellison, in light of the fact that very few European biotechnology companies have the skills and facilities to take biopharmaceuticals from preclinical development through to market, a point made by Celltech CEO Goran Ando in a preface to the E&Y report.

Construction has already started for the £30 million (€44.8mn) NBC, which will be located at Speke in Liverpool and is due to come online in 2006. To help fund its share of the project, Eden has just raised £5 million in private placements.

The unit will have three process development suites and three current Good Manufacturing Practice (cGMP) facilities that should produce enough material for Phase I/II trials, or even commercial production for small-volume products. So in addition to operating as a contract manufacturing organisation, the NBC will offer product development services designed to fill skill and resource gaps that exist within biotech SMEs.

The facility will be able to offer microbial, mammalian and viral manufacturing, and will make use of the latest technologies to make production as cost-effective as possible. This will likely include extensive use of disposable process materials, noted Ellison.

Access fund

The UK government is contributing funding to the project, including £3 million that will be used to help UK biotech small and medium-sized enterprises (SMEs) to purchase services from the National Biomanufacturing Centre.

Ellison said that the access fund is open only to UK companies, which can receive up to £60,000 without any strings attached for projects put through the NBC. For larger projects, the first £60,000 will be on the same principle but additional funding above this level will have to be matched by the sponsor.

Eden said that it won the competitive tender for the contract due to its 'extensive expertise in all aspects of biopharmaceutical manufacturing, and in particular its experience in early stage development'. Ellison and Eden CEO Crawford Brown both hail from Medeva, a UK biotechnology firm - eventually acquired by Celltech - that successfully brought a new recombinant hepatitis B vaccine from early development through to market.

And while the public sector goals are extremely important, Eden is conscious of the limited scope for profits within this function and plans to sell surplus capacity at the NBC in the international marketplace.

To this end, the company has appointed a new chairman, Tony Allen, whose previous roles include managing Fisons' world wide pharmaceutical business. The previous chairman, Iain Ross, along with existing non-executive director Peter Cozens, will now switch focus to develop Eden's international businesses.

Recognising the challenges facing the UK sector, in May the government announced a series of measures designed to support the biotech industry in a £150 million, three-year project.

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