Funding competition Mechanising and improving advanced therapy manufacture

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

This competition is now closed.

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Competition sections

Description

Innovate UK, as part of UK Research and Innovation, will invest up to £3.7 million 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.

The competition closes at midday 12pm UK time on the deadline stated.

Funding type

Grant

Project size

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

Who can apply

State aid

Any UK business claiming funding must be eligible to receive state aid at the time we confirm you will be awarded funding. It is not possible to award grant funding to organisations meeting the condition known as Undertakings in Difficulty. If you are unsure please take legal advice. For further information see our general guidance.

Your project

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

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

If your project’s total eligible costs or duration fall outside of our eligibility criteria, you must provide justification by email to support@innovateuk.ukri.org at least 10 days before the competition closes. We will decide whether to approve your request.

Lead organisation

To lead a project your organisation must:

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.

Project team

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.

Multiple applications

Any one business can lead on one application and collaborate in a further 2 applications.

If a business is not leading an application, they can collaborate in up to 3 applications.

Research organisations can collaborate on any number of applications.

Previous applications

Resubmissions

You can use a resubmission to apply for this competition. A resubmission is a proposal Innovate UK judges as not materially different from one you have submitted before. It can be updated based on the assessors' feedback.

If you submit a new proposal this time you will be able to use it in no more than one future competition that allows resubmissions.

Failure to exploit

If you applied to a previous competition as the lead or sole organisation and were awarded funding by Innovate UK or UK Research and Innovation, but did not make a substantial effort to exploit that award, we will award no more funding to you, in this or any other competition. You will not be able to contest our decision. We will:

  • assess your efforts in the previous competition against your exploitation plan for that project
  • review the monitoring officers’ reports and any other relevant sources for evidence
  • document our decision, which will be made by 3 team members, and communicate it to you in writing

Previous projects

Under the terms of Innovate UK funding, you are required to submit an independent accountant’s report (IAR) with your final claim. If you or any organisation in your consortium failed to submit an IAR on a previous project, we will not award funding to you in this or any other competition until we have received the documents.

Funding

We have allocated up to £3.7 million 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.

Your proposal

We 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.

We 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.

We 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.

Specific themes

Your project must focus one or more of the following:
  • gene therapy
  • engineered tissue
  • cell therapy

Research categories

We will fund industrial research projects as defined in the general guidance

Projects we will not fund

We 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

12 August 2019
Publication date
27 August 2019
Competition opens
3 September 2019
Online briefing event
25 September 2019 12:00pm
Competition closes
1 November 2019
Applicants notified

Before you start

You must read the general guidance for applicants before you start.

What we will ask you

The application is split into 3 sections:

1. Project details.

2. Application questions.

3. Finances.

Project details

This section sets the scene for the assessors and is not scored.

Application team

Decide which organisations will work with you on the project. Invite people from those organisations to help complete the application.

Application details

The lead applicant must complete this section. Give your project’s title, start date and duration. Is the application a resubmission?

Research category

Select the type of research you will undertake.

Project summary

Describe your project briefly, and be clear about what makes it innovative. We use this section to assign experts to assess your application.

Your answer can be up to 400 words long.

Public description

Describe your project in detail, and in a way that you are happy to see published. Do not include any commercially sensitive information. If we award your project funding, we will publish this description. This could happen before you start your project.

Your answer can be up to 400 words long.

Scope

Describe how your project fits the scope of the competition. If your project is not in scope it will be immediately rejected and will not be sent for assessment. We will give you feedback on why. Your answer can be up to 400 words long.

Application questions

The assessors will score your answers. You will receive feedback from them for each one.

Your answer to each question can be up to 400 words long. Do not include any URLs in your answers.

Question 1. Need or challenge

What is the business need, technological challenge or market opportunity behind your innovation?

Describe or explain:

  • the main motivation for the project
  • the business need, technological challenge or market opportunity
  • the nearest current state-of-the-art, including those near market or in development, and its limitations
  • any work you have already done to respond to this need, for example if the project focuses on developing an existing capability or building a new one
  • any links to existing projects funded by Innovate UK, such as for the ‘Advanced therapy treatment centres’ or the ‘Medicines manufacturing collaborative research and development competitions
  • any alignment to regional initiatives such as those started through Local Enterprise Partnerships
  • the wider economic, social, environmental, cultural or political challenges which are influential in creating the opportunity, such as incoming regulations, using our Horizons Tool if appropriate

Question 2. Approach and innovation

What approach will you take and where will the focus of the innovation be?

Describe or explain:

  • how you will respond to the need, challenge or opportunity identified
  • how you will improve on the nearest current state-of-the-art identified
  • whether the innovation will focus on the application of existing technologies in new areas, the development of new technologies for existing areas or a totally disruptive approach
  • the freedom you have to operate
  • how this project fits with your current product, service lines or offerings
  • how it will make you more competitive
  • the nature of the outputs you expect from the project (for example report, demonstrator, know-how, new process, product or service design) and how these will help you to target the need, challenge or opportunity identified

You can submit charts, diagrams or data as an appendix to support your answer. It must be a PDF and can be up to 2 pages long. The font must be legible at 100% zoom.

Question 3. Team and resources

Who is in the project team and what are their roles?

Describe or explain:

  • the roles, skills and experience of all members of the project team that are relevant to the approach you will be taking
  • the resources, equipment and facilities needed for the project and how you will access them
  • the details of any vital external parties, including sub-contractors, who you will need to work with to successfully carry out the project
  • the current relationships between project partners and how these will change as a result of the project
  • any roles you will need to recruit for

You can submit a short summary on the main people working on the project as an appendix to support your answer. It must be a PDF and can be up to 4 pages long. The font must be legible at 100% zoom.

Question 4. Market awareness

What does the market you are targeting look like?

Describe or explain:

  • the markets (domestic, international or both) you will be targeting in the project, and any other potential markets
  • the size of the target markets for the project outcomes, backed up by references where available
  • the structure and dynamics of the target markets, including customer segmentation, together with predicted growth rates within clear timeframes
  • the target markets’ main supply or value chains and business models, and any barriers to entry that exist
  • the current UK position in targeting these markets
  • the size and main features of any other markets not already listed
If your project is highly innovative, where the market may be unexplored, describe or explain:

  • what the market’s size might to be
  • how your project will try to explore the market’s potential

Question 5. Outcomes and route to market

How are you going to grow your business and increase your productivity into the long term as a result of the project?

Describe or explain:

  • your current position in the markets and supply or value chains outlined, and whether you will be extending or establishing your market position
  • your target customers or end users, and the value to them, for example why they would use or buy your product
  • your route to market
  • how you are going to profit from the innovation, including increased revenues or cost reduction
  • how the innovation will affect your productivity and growth, in both the short and the long term
  • how you will protect and exploit the outputs of the project, for example through know-how, patenting, designs or changes to your business model
  • your strategy for targeting the other markets you have identified during or after the project

If there is any research organisation activity in the project, describe:

  • your plans to spread the project’s research outputs over a reasonable timescale
  • how you expect to use the results generated from the project in further research activities

Question 6. Wider impacts

What impact might this project have outside the project team?

Describe, and where possible measure:

  • the economic benefits from the project to external parties, including customers, others in the supply chain, broader industry and the UK economy, such as productivity increases and import substitution
  • any expected impact on government priorities
  • any expected environmental impacts, either positive or negative
  • any expected regional impacts of the project

Describe any expected social impacts, either positive or negative on, for example:

  • quality of life
  • social inclusion or exclusion
  • jobs, such as safeguarding, creating, changing or displacing them
  • education
  • public empowerment
  • health and safety
  • regulations
  • diversity

Question 7. Project management

How will you manage the project effectively?

Describe or explain:

  • the main work packages of the project, indicating the lead partner assigned to each and the total cost of each one
  • your approach to project management, identifying any major tools and mechanisms you will use to get a successful and innovative project outcome
  • the management reporting lines
  • your project plan in enough detail to identify any links or dependencies between work packages or milestones

You must submit a project plan or Gantt chart as an appendix to support your answer. It must be a PDF and can be up to 2 pages long. The font must be legible at 100% zoom.

Question 8. Risks

What are the main risks for this project?

Describe or explain:

  • the main risks and uncertainties of the project, including the technical, commercial, managerial and environmental risks, providing a risk register if appropriate
  • how you will mitigate these risks
  • any project inputs that are critical to completion, such as resources, expertise, data sets
  • any output likely to be subject to regulatory requirements, certification, ethical issues and so on, and how you will manage this

You must submit a risk register as an appendix to support your answer. It must be a PDF and can be up to 2 pages long. The font must be legible at 100% zoom.

Question 9. Added value

What impact would an injection of public funding have on the businesses involved?

Describe or explain:

  • if this project could go ahead in any form without public funding and if so, the difference the public funding would make, such as a faster route to market, more partners or reduced risk
  • the likely impact of the project on the businesses of the partners involved
  • why you are not able to wholly fund the project from your own resources or other forms of private-sector funding, and what would happen if the application is unsuccessful
  • how this project would change the nature of R&D activity the partners would undertake, and the related spend

Question 10. Costs and value for money

How much will the project cost and how does it represent value for money for the team and the taxpayer?

Describe or explain:

  • the total eligible project costs and the grant you are requesting in terms of the project goals
  • how each partner will finance their contributions to the project
  • how this project represents value for money for you and the taxpayer
  • how it compares to what you would spend your money on otherwise
  • the balance of costs and grant across the project partners
  • any sub-contractor costs and why they are critical to the project

Finances

Each organisation in your project must complete their own project costs, organisation details and funding details. Academic institutions will need to complete and upload a Je-S form. For full details on what costs you can claim please see our project costs guidance.

Background and further information

If you want help to find a project partner, contact the Knowledge Transfer Network.

If you need more information, email us at support@innovateuk.ukri.org or call the competition helpline on 0300 321 4357 between 9am and 5:30pm, Monday to Friday.

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