Soon after the announcement of the establishment of the Medicines Manufacturing Industry Partnership, this lively workshop at the UK Bioscience Forum enjoyed significant engagement across the community. Overall themes running through the case studies on new facility builds presented in this session include:
- the importance of funding
- collaborative approach with the MHRA
- the opportunities single-use technologies bring, but not without supply chain challenges
James Christie, Head of Manufacturing at Oxford BioMedica, opened the session by highlighting the significance of the sector to the UK economy. The UK medicines manufacturing industry is one of our leading manufacturing sectors, worth £22bn in exports, generating a trade surplus of £4.9bn in 2012 and Gross Value Added (GVA) per head of £149k, significantly higher than any other industry.
In 2012, 84% of the global pharmaceutical market by value was small molecules and 16% biologics/cell and gene therapies. Industry pipelines suggest that this will move towards a 50/50 split. Today, already 70% of the top 10 globally selling medicines are biologics compared to only 20% in 2006.
James then discussed the factors that make the UK attractive for medicines manufacturing. These include:
- support from the Trade Associations and The Knowledge Transfer Network (KTN)
- fiscal incentives such as the Patent Box
- a great skill base that is now being supported further through the Science and Industry Partnership (SIP), which received £65.7m of public and private investment and involves 100 employers
- BIS funding through the Advanced Manufacturing Supply Chain Initiative (AMSCI) which has resulted in two successful bids led by Oxford BioMedica (centre of excellence for gene based therapies) and GSK (continuous manufacturing) totalling £30.7 million. There has been a recent announcement by BIS of a further round of AMSCI funding to the tune of £100m.
To ensure that medicines manufacturing continues to be the UK’s No1 export earning sector through 2020 and beyond by differentiating, defending and growing the existing manufacturing base, recent government interest has resulted in the establishment of the Medicines Manufacturing Industrial Partnership (MMIP) which brings industry together to work towards this common goal of creating an attractive and innovation-driven environment for all types of medicines manufacturing.
Other recent government investments to support manufacturing include the National Biologics Manufacturing Centre (NBMC) in Darlington, and funding for a manufacturing facility for the cell therapy catapult totalling £55 million, which will allow the UK to work towards anchoring manufacturing of this growing sector in the UK.
As well as new manufacturing in the UK, re-shoring is equally as important. The announcement by GlaxoSmithKline that a new biologics manufacturing facility would be built at Ulverston was a testament to the competitiveness of the UK.
Crawford Brown, CEO of Actavis Biologics, a biosimilars manufacturer in Liverpool, ran through the history of the company. This facility started out as the government-funded project known as the National Biomanufacturing Centre, and following its acquisition by Actavis is now the Global Centre of Excellence for development and manufacture of all biologic medicines within the Actavis Group. The biologics R&D site has state-of-the-art facilities and world-class development and manufacturing technologies.
Chris Major, BioProcess Manager of GE Healthcare, presented a complete solution to manufacturing in growing economies where governments are investing for self-sufficiency. KUBio and Flex Factory enable a GMP factory to be constructed out of the box, using single use technologies, which includes validation, training and even the finance to fund the project if required.
Single Use technologies were also championed by Mike Quin, Asset Manager at FUJIFILM Diosynth Biotechnologies, as a key component of their recently opened cell culture manufacturing facility in Billingham. As they run a multi-product facility, single use technologies reduce changeover times and minimise cleaning and validation, but the reliance on supply chain is greater. Input from the MHRA was sought from the design stage to ensure a future-proof factory was built and a modular design allows for an expandable facility
Simon Saxby, Interim Project Director at Cell Therapy Catapult, outlined how the government initially conceived the Cell Therapy Catapult to address key industry barriers in the area, and then went on to invest further in the Cell Therapy Manufacturing Centre, which will operate as an Advanced Therapy Medicinal Products (ATMP) manufacturing hotel to anchor cell therapy manufacturing in the UK. This facility will be modular, flexible, expandable and employ single use technologies, with final site selection to be announced soon.