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Microbiology, Cell, Gene, DNA

Mechanising and improving advanced therapy manufacture

Overview:

UK businesses can apply for a share of up to £3.7million for research and development projects to improve manufacturing of advanced therapies. This funding is from the Industrial Strategy Challenge Fund.

Innovate UK, as part of UK Research and Innovation, will invest up to £3.7million in innovation projects. These will be to allow robust process design for the manufacture of advanced therapies.

The aim of this competition is to encourage inventors of advanced therapies to introduce affordable technology during early innovation stages. This technology will enable them to reproduce the manufacture of their product at a commercial scale.

Your proposal should describe how new tools will make the manufacture of the product less dependent on human operators. Industry co-funding must be contributed at a rate of no less than 50% of total project costs.

Your application must be collaborative.

Open Date:

27/08/2019

Close Date:

25/09/2019

Innovate UK aim to encourage inventors of advanced therapies to introduce affordable technology early in their process development. This technology will enable them to make the manufacture of their product commercially reproducible.

Innovate UK want to encourage process mechanisation that relies on external technology rather than improving existing technology for commercial manufacture. This should help technology to transfer from academia to industry, and support multi-site manufacture for appropriate goods. These could be those manufactured close to clinic or in regional hubs.

Innovate UK do not expect you to fully develop the final drug product during the project but your work must contain its characteristics.

Your proposal must describe how you will demonstrate the following ‘Success Factors’ during execution. The international guidance will give further information on the bulleted list below.

Your project must:

  • Identify the variables that affect the production process and have the most impact on the product’s properties
  • Provide statistical evidence to justify your choice of process variables
  • Provide a control strategy that identifies the limits within which the process variables can change, either alone or together, without adversely affecting process capability
  • Give evidence of process improvement to show that when the control strategy is applied, the rate of process failure is reduced significantly and to below 5%
  • Give evidence that the rate of failure is not significantly influenced by changes in trained manufacturing personnel
  • Have a prototype mechanisation device and a specification that expresses its important features

You must show how your project will increase the productivity, competitiveness, capability or growth of at least one UK business involved in the project.

Projects should aim to work with bodies that generate standards, such as the National Physical Laboratory, the LGC Group (formerly Laboratory of the Government Chemist), BSI (British Standards Institute) or the National Institute for Biological Standards and Control.

Your project must focus one or more of the following:

  • Gene therapy
  • Engineered tissue
  • Cell therapy

Any UK business claiming funding must be eligible to receive state aid at the time Innovate UK confirm you will be awarded funding. It is not possible to award grant funding to organisations meeting the condition known as Undertakings in Difficulty.

Your project’s total eligible costs must be between £1million and £2million.

Projects must start by 1 February 2020 and end by 31 March 2021. They can last between 12 and 14 months.

To lead a project your organisation must:

  • Be a UK-registered business, of any size
  • Collaborate with one or more UK businesses, research organisations, public sector organisations or charities
  • Carry out its project work in the UK
  • Intend to exploit the results from or in the UK

Academic institutions cannot lead.

Your project can include partners that do not receive any of this competition’s funding, for example non-UK businesses. Their costs will count towards the total eligible project costs.

To collaborate with the lead organisation your organisation must:

  • Be a UK-registered business (to claim grant funding), academic institution, charity, public sector organisation or research and technology organisation (RTO)
  • Carry out its project work in the UK
  • Intend to exploit the results from or in the UK
  • Be invited to take part by the lead applicant

The lead applicant and at least one other organisation must claim funding and enter their costs as part of the application.

Any one business can lead on one application and collaborate in a further two applications.

If a business is not leading an application, they can collaborate in up to three applications.

Research organisations can collaborate on any number of applications.

Innovate UK have allocated up to £3.7million to fund innovation projects in this competition.

Total project grant funding must not exceed 50% of your total eligible project costs. This is regardless of individual partners’ claims. Of that 50%, individual partners can claim grant funding of:

  • Up to 70% if you are a micro or small business
  • Up to 60% if you are a medium-sized business
  • Up to 50% if you are a large business

The research organisations in your consortium can share up to 30% of the total eligible project costs. If your consortium contains more than one research organisation, this maximum is shared between them.

This competition provides state aid funding under article 25, ‘Collaborative R&D – Industrial Research’, of the General Block Exemption Regulation (GBER). It is your responsibility to make sure that your organisation is eligible to receive state aid.

Innovate UK are not funding:

  • Incremental process improvements that are unlikely to result in a significant change to costs, batch loss or resource usage
  • The discovery of medicines
  • Non-commercial manufacturing applications
  • Technology for the manufacture of medicines for non-human use, except as a demonstrator with a clear process design link to a human drug product
  • Enhancements to manufacture that rely primarily on existing technology

Cresco Innovation works with companies to develop and implement innovation strategies. We help client companies identify opportunities to develop new products and services, and then create a package of support to ensure that the idea is turned into a commercial reality.

Our services include securing grants (as a team we have raised around £40million over three years), business planning, IP advice, access to finance and funders, project management and IP commercialisation support.

We regularly act as the interface with the funding bodies and help clients ensure that their projects are properly managed to ensure the best outcome for all.

Call to find out more

If you’d like to know more about this competition, please give us a call on 01509 261182 and one of our team will be delighted to help you access this funding opportunity for your business.