Notice

Competition brief: cell & gene therapies industrial manufacture

Updated 16 November 2016

This notice was withdrawn on 21 September 2017

This competition is no longer open. Search current funding opportunities.

1. Dates and deadlines

Competition opens	Monday 26 September 2016
Briefing event for applicants	Wednesday 5 October 2016
Registration deadline	Noon on Wednesday 16 November 2016
Application deadline	Noon on Wednesday 23 November 2016

2. The competition scope

The aim of this competition is to stimulate UK manufacturing for businesses developing novel cell and gene therapies. Projects must focus on the industrialisation of the current manufacturing process for a cell or gene therapy. We are particularly interested in funding projects that address one or more of the following:

• the transfer of cell and gene therapies from the clinical stage to a commercially viable product made in a facility licensed by the Medicines & Healthcare products Regulatory Agency (MHRA)
• process validation within a large-scale commercial facility
• transfer of technology from small-scale manufacturing to a large-scale innovative Good Manufacturing Practice (GMP) manufacturing facility
• regulatory support and market approval applications of the product
• the establishment of logistics and reliable end-to-end supply chains for businesses in the UK
• the development of a UK cell and gene therapy manufacturing capability and the systems to enable efficient manufacturing for multiple businesses in a cluster or single location

You must also show how your project will improve business growth, productivity and/or export opportunities for at least one UK SME involved in the project.

3. Projects that we won’t fund

In this competition we are not funding projects:

• developing an advanced therapy specifically for non-human use
• manufacturing products that cannot demonstrate impact on human health
• working with manufacturing processes that cannot show repeatable operation under GMP guidelines within a rigorous quality control system
• focused on the preclinical discovery of a new advanced therapy
• manufacturing within an academic or clinically managed facility

4. Find out if you are eligible to apply

To lead a project, you must:

• be a UK-based business
• be a business of any size
• carry out your project in the UK
• work in collaboration with others (for example, businesses, research organisations and third sector)

International partners are welcome to take part in a project but they are not eligible for Innovate UK funding.

5. Funding and project details

We have allocated up to £11 million to fund collaborative research and development projects in this competition.

All projects must involve at least one SME and a business must lead the project.

5.1 Project types

We expect projects to focus mostly on industrial research, although there may be some elements of experimental development.

For industrial research, you could get:

• up to 70% of your eligible project costs if you are a small business
• up to 60% if you are a medium-sized business
• up to 50% if you are a large business

For projects that include experimental development work packages, for each of these work packages you could get:

• up to 45% of your eligible project costs if you are a small business
• up to 35% if you are a medium-sized business
• up to 25% if you are a large business

For more information on the research category definitions, read the guidance for applicants.

Find out if your business fits the EU definition of an SME.

We expect projects to last 1 to 3 years. We expect them to range in size from total costs of £1 million to £2.5 million. If your total project costs are outside this range, please contact us to discuss this before 2 November 2016.

6. How to apply

To apply:

• the lead applicant must register online
• read the guidance for applicants for this competition
• attend the briefing event for potential applicants in London on 5 October 2016 in person or by webinar
• complete and submit your online application on our secure server

We will not accept late submissions. Your application is confidential.

External, independent experts assess the quality of your application. We will then select the projects that we fund, to build a portfolio of projects that:

• are high quality
• meet the industry-building aims of this competition
• reflect a range as described in the scope
• address opportunities across a range of diseases and therapies

Read the general guidance for applicants carefully before you apply. It will help your chances of submitting a successful application.

7. Background and further information

The 2014 Budget announced an investment to create a UK Cell and Gene Therapy Manufacturing Centre. Based in Stevenage, the centre is due to open in May 2017. It will be run by the Cell and Gene Therapy Catapult, enabling large-scale manufacture of cell and gene therapies for late-stage clinical trials and commercial supply. The funding for this competition is part of the investment to establish the UK Cell and Gene Therapy Manufacturing Centre.

Advanced therapies, including cell and gene therapies, represent a priority area for Innovate UK’s Health and Life Sciences Sector. The UK has world-leading expertise in cell therapeutics and gene therapy. This is both in the science underpinning discovery and in the ability to progress therapies to clinical testing.

Developing cell and gene therapies will be particularly important in areas of unmet clinical need. These include some common conditions, such as blindness, cancer, heart failure, liver disease and neurological conditions, but also rare and paediatric diseases. Around 30% of the UK population suffer from a chronic disease. The World Health Organization has estimated that the UK loses $3.4 billion in income per year, as a result of deaths from chronic conditions. The cost of management of chronic disease accounts for 70 to 75% of all UK healthcare costs. Estimates put the global market for the advanced therapies sector at more than £60 billion by 2020.

Recently, there have been technological advances and increased evidence of clinical applicability for cell and gene therapies. This provides a significant opportunity to make the UK a global leader in this industry.

The last 2 years have seen pioneering, new UK-based cell and gene therapy companies formed. They are developing and commercialising advanced therapies. A major hurdle for SMEs developing these innovative therapies is manufacturing at scale for late-stage clinical trials and market supply.

This competition is seeking to address these critical challenges. It will enable industrial growth and develop links into the manufacturing supply chain. The competition will also create opportunities for engagement with the Cell and Gene Therapy Catapult, and use of the Cell and Gene Therapy Manufacturing Centre.

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

If you need more information, please contact the competition helpline on 0300 321 4357 or email us at support@innovateuk.gov.uk.