Mechanising and improving advanced therapy manufacture

Overview

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.

Scope

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.

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.

You are not expected to fully develop the final drug product during the project but your work must contain its characteristics.

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:

Eligibility

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.

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.

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.

Funding Costs

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

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.

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

Exclusions

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