Biologics Update – November 2014

An update on the build of CPI’s Biologics Manufacturing Centre

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CPI is a key partner in H2020 consortium to develop Nanopharmaceuticals

The Centre for Process Innovation (CPI) is part of a consortium which will focus on the development and scale up of nanopharmaceutical production. Coordinated by Midatech Biogune, part of the UK based Midatech Pharma, the project aims to scale up an existing Gold Nanoparticle (GNP) production process to meet the projected demands associated with Midatech‘s clinical pipeline in endocrine and oncology therapies.

Specifically, this project will focus on the manufacture of insulin coated gold nanoparticles, that are being used in Midatech‘s insulin delivery patch. The outcomes of the project will also support the development of nanoparticle based therapies to address other disease areas.

CPI will deploy its bioprocessing and chemistry expertise and facilities to support the manufacturing scale up of nanoparticle generation, insulin coating and final purification. The funding will also allow CPI to establish the infrastructure which other Nanopharmaceutical companies can access to support process development and scale up. The project will leverage and enhance the expertise and knowledge of the nine companies and academic centres of excellence across Europe that form the consortium, leaving a legacy that will support the further growth of this emerging high potential technology.

Dr Chris Dowle, Director of Biologics at CPI said: Helping to secure the funding for this project is a significant milestone for CPI. Beating off competition from an extremely competitive environment, CPI was able to assist Midatech in gaining the relevant funding it needs to move forward with the project, an obstacle which is often difficult to overcome for an SME. We are extremely proud to be able to work with Midatech and the other consortium members on what promises to be a very exciting project.”

Dr Jim Phillips, CEO of Midatech said: We are delighted to have joined forces with CPI on this project, they have provided a high level support and are an ideal partner going forward together with the other consortium members. Midatech is looking forward to a highly productive and fruitful collaboration which will form a key part of our portfolio development.”

National Biologics Manufacturing Centre

  • NBMC is open for business now through our laboratory and clean room set up at the Wilton Site.
  • Capabilities at Wilton as set-up today are analytical, downstream processing and high throughput process development.
  • Process equipment tendering is 90% complete with 70% specified.
  • The NBMC facility in Darlington is proceeding well and will be watertight by January.
  • The build is on target for an official opening event in quarter 2 2015.
  • Access to the build commences 10th April and progressively all 129 equipment items will be brought on-line from then. Process equipment will be online in Darlington and ready to deliver the current awarded CR&D projects; Horizon 2020 project Nanomanufacturing’ with Midatech starting June 2015, IB Catalyst project with Arecor and FFDB starting May 2015 and IB Catalyst project with Horizon and Manchester University December 2015.
  • The informatics infrastructure implementation will commence in December.
  • CPI Biologics has recruited a team of highly skilled scientists and engineers who are currently running as a cohesive unit out of our temporary offices at Teeside University, Darlington.
  • The proximity to site is enabling us to work closely with Interserve on the design, build and coordination of CPI Biologics moving into the facility.
  • We will be looking to grow our team of highly skilled scientists and engineers to meet the demand required to deliver both themes and projects.
  • We will be delighted to explore potential collaborations and business opportunities with you.

The National Horizons Centre

equipmentIn July 2014 the Centre for Process Innovation (CPI) announced that it will enter into partnership with Teesside University, Darlington College and the Centre for Subsea Technology Awareness, Training and Education (C‑STATE) to develop the £30million National Horizons Centre (NHC) to be based in Darlington.

The centre is to be located within the Central Park development in Darlington, a multi-million pound development that will include residential housing, a leisure park, a Business Growth Hub and the National Biologics Manufacturing Centre.

With £17.5m of local growth fund support earmarked for the project, the NHC aims to develop the practical skills required within industries such as biopharmaceuticals, industrial biotechnology, subsea engineering and digital media, all of which will play a significant part in the future growth of the UK economy.

The National Horizons Centre will enhance skills, leadership and innovation within these key industries and will deliver high-quality, specialist training and development, at all levels, from post-16 study through to postgraduate and CPD courses.

Judi Sutherland, CPI’s National Horizons Centre Project Manager, said: The National Horizons Centre will fill a significant skills gap in the bioprocess industries and in subsea engineering, where there are fulfilling careers available, but employers find it difficult to recruit candidates with the right skill sets. The central Darlington location provides synergy with CPI’s National Biologics Manufacturing Centre, opening in 2015, and the teaching facilities of Darlington College and Teesside University. In addition, being located alongside Darlington Train Station it will allow easy travel from the UK’s major cities”

Dr Chris Dowle, Director at CPI, added: We are delighted to be part of this collaborative partnership to deliver skills and workforce development in key areas of manufacturing for the bioeconomy and the future prosperity of the UK.”

Factory of the Future

One size fits all therapies Today most therapeutic products are administered to large populations of people, and therefore manufacture tends to be geared towards large volumes of therapies, often in centralised, dedicated manufacturing facilities. The final products are shipped around the world to the point of use.

Meeting the challenge of delivering personalised medicines DNA sequencing technologies are facilitating a more thorough understanding of causative mechanisms of diseases, enabling the differentiation of single diseases into multiple subtypes on the basis of underlying genetic factors. For example, breast cancer can now be categorised into 10 different types, which explains why some patients respond to therapies, whilst others with similar physical symptoms do not.

The provision of medicines to patients is undergoing a radical change from one size fits all” medicines to a personalised approach. This will have a significant impact on the established medicines supply chain, from production of relatively large volumes of single therapies, to small scale manufacture of a more diverse range of therapies. The use of modular or mass customised factories” will facilitate the small scale, agile production of a diverse range of therapies that the provision of healthcare in the future, will demand. The so called pharmaceutical factory of the future” will be an integration of the current manufacturing technologies, into small format multipurpose units that can be rapidly reconfigured to produce small amounts of a diverse range of therapies. Existing pharmaceutical manufacturers will have multiple small scale production units which can be deployed flexibly to meet the increase in variety of therapies.

Distributed manufacture of personalised medicines As personalised medicine becomes more bespoke, the case for localised manufacture of therapeutics starts to build. The small format manufacturing unit could be deployed in secondary care settings, enabling a close coupling between real time point of care diagnostics and the manufacture of the most effective therapy based on the patient’s biological characteristics. In addition in remote locations in the developing world, it would be possible to locate manufacturing close to a community to produce therapies or vaccines to combat an outbreak of infectious disease.

The window of opportunity to develop the small format factory of the future is short, but the rewards for successful innovators could be significant.