Innovative technologies for nucleic acid medicines manufacturing
UK registered organisations can apply for a share of up to £5 million for manufacturing innovation for nucleic acid medicines. This funding is from Innovate UK.
- Competition opens: Monday 7 November 2022
- Competition closes: Wednesday 21 December 2022 11:00am
This competition is now closed.
Competition sections
Description
Innovate UK, part of UK Research and Innovation, will invest up to £5 million in innovation projects. These will be to develop and commercialise innovative solutions for the manufacturing of nucleic acid medicines.
The aim of this competition is to improve the resource efficiency, productivity and scalability for the manufacture of nucleic acid medicines in the UK.
Your proposal must show how your project will improve the productivity, competitiveness and growth for at least one UK small or medium-sized enterprise (SME) involved in the project.
In applying to this competition, you are entering into a competitive process. This competition closes at 11am UK time on the deadline stated.Funding type
Grant
Project size
Your project’s total grant funding request must be between £100,000 and £2 million.
Who can apply
Your project
Your project must:
- have a grant award between £100,000 and £2 million
- start by 1 June 2023
- end by 31 May 2025
- last between 12 and 24 months
- carry out all of its project work in the UK
- intend to exploit the results from or in the UK
You must only include eligible project costs in your application.
Under current restrictions, this competition will not fund any procurement, commercial, business development or supply chain activity with any Russian or Belarusian entity as lead, partner or subcontractor. This includes any goods or services originating from a Russian or Belarusian source.
If your total project’s costs or duration falls outside of our eligibility criteria, you must provide justification by email to support@iuk.ukri.org at least 10 working days before the competition closes. We will decide whether to approve your request.
If you have not requested approval or your application has not been approved by us, you will be made ineligible. Your application will then not be sent for assessment.
Lead organisation
To lead a project your organisation must:
- be a UK registered business of any size or a research and technology organisation (RTO), not for profit or public sector organisation
- collaborate with other UK registered organisations
- be or involve at least one grant claiming micro, small or medium-sized enterprise (SME)
More information on the different types of organisation can be found in our Funding rules.
If the lead organisation is an RTO it must collaborate with 2 businesses (one SME, and one business of any size).
Academic institutions cannot lead or work alone.
Project team
To collaborate with the lead, your organisation must be one of the following UK registered:
- business of any size
- academic institution
- charity
- not for profit
- public sector organisation
- research and technology organisation (RTO)
Each partner organisation must be invited into the Innovation Funding Service by the lead to collaborate on a project. Once accepted, partners will be asked to login or to create an account and enter their own project costs into the Innovation Funding Service.
To be an eligible collaboration, the lead and at least one other organisation must apply for funding when entering their costs into the application.
Non-funded partners
Your project can include partners that do not receive any of this competition’s funding. Their costs will count towards the total project costs.
Subcontractors
Subcontractors are allowed in this competition.
Subcontractors can be from anywhere in the UK and you must select them through your usual procurement process.
You can use subcontractors from overseas but must make the case in your application as to why you could not use suppliers from the UK.
You must provide a detailed rationale, evidence of the potential UK contractors you approached and the reasons why they were unable to work with you. We will not accept a cheaper cost as a sufficient reason to use an overseas subcontractor.
All subcontractor costs must be justified and appropriate to the total project costs.
Number of applications
A business, research and technology organisation (RTO), charity, not for profit or public sector organisation can only lead on one application but can be included as a collaborator in a further 2 applications.
If a business, RTO, charity, not for profit or public sector organisation is not leading any application, it can collaborate in any number of applications.
An academic institute can collaborate on any number of applications.Previous applications
You can use a previously submitted application to apply for this competition.
We will not award you funding if you have:
- failed to exploit a previously funded project
- an overdue independent accountant’s report
- failed to comply with grant terms and conditions
Subsidy control (and State aid where applicable)
This competition provides funding in line with the UK's obligations and commitments to Subsidy Control. Further information about the UK Subsidy Control requirements can be found within the EU-UK Trade and Cooperation agreement and the subsequent guidance from the department of Business, Energy and Industrial Strategy (BEIS).
Innovate UK is unable to award organisations that are considered to be in financial difficulty. We will conduct financial viability and eligibility tests to confirm this is not the case following the application stage.
EU State aid rules now only apply in limited circumstances. Please see our general guidance to check if these rules apply to your organisation.
Further Information
If you are unsure about your obligations under the UK Subsidy Control regime or the State aid rules, you should take independent legal advice. We are unable to advise on individual eligibility or legal obligations.
You must at all times make sure that the funding awarded to you is compliant with all current Subsidy Control legislation applicable in the United Kingdom.
This aims to regulate any advantage granted by a public sector body which threatens to, or actually distorts competition in the United Kingdom or any other country or countries.
If there are any changes to the above requirements that mean we need to change the terms of this competition, we will tell you as soon as possible.
Funding
Up to £5 million has been allocated to fund innovation projects in this competition. Funding will be in the form of a grant.
If your organisation’s work on the project is commercial or economic, your funding request must not exceed the limits below. These limits apply even if your organisation normally acts non-economically but for the purpose of this project will be undertaking commercial or economic activity.
For industrial research projects, you could get funding for your eligible project costs of:
- up to 70% if you are a micro or small organisation
- up to 60% if you are a medium sized organisation
- up to 50% if you are a large organisation
For more information on company sizes, please refer to the company accounts guidance. This is a change from the EU definition unless you are applying under State aid.
If you are applying for an award funded under State aid Regulations, the definitions are set out in the European Commission Recommendation of 6 May 2003.
Research participation
The research organisations undertaking non-economic activity as part of the project can share up to 80% of the total eligible project costs. If your consortium contains more than one research organisation undertaking non-economic activity, this maximum is shared between them. Of that 80% you could get funding for your eligible project costs of up to:
- 80% of full economic costs (FEC) if you are a Je-S registered institution such as an academic
- 100% of your project costs if you are an RTO, charity, not for profit organisation, public sector organisation or research organisation
Your proposal
The aim of this competition is to improve the resource efficiency, productivity and scalability for the manufacture of nucleic acid medicines in the UK.
Our objective is to stimulate the development and implementation of innovative technologies to improve the resource efficiency, productivity and ability to manufacture nucleic acid-based medicine. This must allow for growth at scale including, but not limited to, emerging products targeting large patient populations.
Your project must be focused on the manufacturing of the active nucleic acid ingredient. You must be able to demonstrate an improvement in resource efficiency, productivity or throughput as compared with current manufacturing technology utilising a recognised metric, for example, with process mass intensity.
The nucleic acid-based active ingredients in scope for this competition include but are not limited to:
- small activating ribonucleic acid (RNA)
- messenger ribonucleic acid (mRNA), including self-amplifying mRNA
- antisense RNA or oligonucleotides
- small interfering, short interfering or silencing RNA
- short hairpin RNA
- Micro RNA
- DNA
Specific themes
Your project must focus on one or more of the following:
- in-process monitoring, control and release testing
- maintenance of product critical quality parameters such as purity, potency and viability
- product characterisation
- process challenges for increasing the scale of production
- transfer of technology from small-scale manufacturing to a good manufacturing practice (GMP) manufacturing facility
- lowering of the cost of goods as final output
- increase in yield of active ingredient
- increase in speed of production cycle
- methods to increase the flexibility of established manufacturing facilities
- adaptation of processes from batch to continuous production
Research categories
Projects we will not fund
We are not funding projects that are:
- wholly lipid nanoparticle, bioconjugation or other formulated nucleic acid product or process development
- for medicines discovery
- manufacturing process innovations using a non-human medicine as the product
We cannot fund projects that are:
- dependent on export performance, for example giving a subsidy to a baker on the condition that it exports a certain quantity of bread to another country
- dependent on domestic inputs usage, for example giving a subsidy to a baker on the condition that it uses 50% UK flour in their product
- 7 November 2022
- Competition opens
- 15 November 2022
- Online briefing event: watch the recording
- 21 December 2022 11:00am
- Competition closes
- 14 February 2023
- Applicants notified
Before you start
You must read the guidance on applying for a competition on the Innovation Funding Service before you start.
Before submitting, it is the lead applicant’s responsibility to make sure:
•that all the information provided in the application is correct
•your proposal meets the eligibility and scope criteria
•all sections of the application are marked as complete
•that all partners have completed all assigned sections and accepted the terms and conditions (T&Cs)
You can reopen your application once submitted, up until the competition deadline. You must resubmit the application before the competition deadline.
What we ask you
The application is split into 3 sections:
- Project details.
- Application questions.
- Finances.
Accessibility and inclusion
Innovate UK is committed to making applications accessible to everyone.
We can provide help for applicants who face barriers when making an application. This might be as a result of a disability, neurodiversity or anything else that makes it difficult to use our services. We can also give help and make other reasonable adjustments for the duration of your project if your application is successful.
If you think you need more support, it is important that you contact our Customer Support Service as early as possible during your application process. You should aim to contact us no later than 15 working days before the competition closing date.
You can email support@iuk.ukri.org or call 0300 321 4357.
Our phone lines are open from 9am to 5pm, Monday to Friday (excluding bank holidays).
1. Project details
This section provides background 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
Give your project’s title, start date and duration.
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 the right 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 not be eligible for funding.
Your answer can be up to 400 words long.2. Application questions
The assessors will score all your answers apart from question 1. You will receive feedback for each scored question. Find out more about how our assessors assess.
You must answer all questions. Your answer to each question can be up to 400 words long. Do not include any website addresses (URLs) in your answers.
Question 1. Applicant location (not scored)
You must state the name and full registered address of your organisation and any partners or subcontractors working on the project.
We are collecting this information to understand the geographical location of all applicants.
Question 2. Need or challenge
What is the business need, technological challenge or market opportunity behind your innovation?
Explain:
- the main motivation for the project
- the business need, technological challenge or market opportunity
- whether you have identified any similar innovation and its current limitations, including those close to market or in development
- 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
- 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 3. Approach and innovation
What approach will you take and where will the focus of the innovation be?
Explain:
- how you will respond to the need, challenge or opportunity identified
- how will you improve on the similar innovation that you have identified
- whether the innovation will focus on 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 one appendix to support your answer. It can include diagrams and charts. It must be a PDF, up to 2 A4 pages long and no larger than 10MB in size. The font must be legible at 100% zoom.
Question 4. Team and resources
Who is in the project team and what are their roles?
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 subcontractors, who you will need to work with to successfully carry out the project
- if your project is collaborative, 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 one appendix. This can include a short summary of the main people working on the project to support your answer. It must be a PDF, up to 4 A4 pages long and no larger than 10MB in size. The font must be legible at 100% zoom.
Question 5. Market awareness
What does the market you are targeting look like?
Describe:
- the target markets for the project outcomes, any other potential markets (domestic, international or both)
- 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 be
- how your project will try to explore the market’s potential
Question 6. Outcomes and route to market
How are you going to grow your business and increase long term productivity as a result of the project?
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 7. Wider impacts
What impact might this project have outside the project team?
Describe and, where possible, measure the economic benefits from the project such as productivity increases and import substitution, to:
- external parties
- customers
- others in the supply chain
- broader industry
- the UK economy
Describe and, where possible, measure:
- 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 8. Project management
How will you manage your project effectively?
Explain:
- the main work packages of your 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, up to 2 A4 pages long and no larger than 10MB in size. The font must be legible at 100% zoom.
Question 9. Risks
What are the main risks for this project?
Explain:
- the main risks and uncertainties of the project, including the technical, commercial, managerial and environmental risks
- how you will mitigate these risks
- any project inputs that are critical to completion, such as resources, expertise, and 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, up to 2 A4 pages long and no larger than 10MB in size. The font must be legible at 100% zoom.
Question 10. Added value
How will this public funding help you to accelerate or enhance your approach to developing your project towards commercialisation? What impact would this award have on the organisations involved?
Explain:
- what advantages would public funding offer your project, for example, appeal to investors, more partners, reduced risk or a faster route to market (this list is not exhaustive)
- the likely impact of the project outcomes on the organisations involved
- what other routes of investment have you already approached
- what your project would look like without public funding
- how this project would change the R&D activities of all the organisations involved
Question 11. 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?
In terms of your project goals, explain:
- your total project costs
- the grant you are requesting
- how each partner will finance their contributions to your 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 subcontractor costs and why they are critical to your project
3. Finances
Each organisation in your project must complete their own project costs, organisation details and funding details in the application. Academic institutions must complete and upload a Je-S form.
For full details on what costs you can claim see our project costs guidance.Background and further information
The global biopharmaceutical market generated $1300 billion revenue in 2020, with forecast growth of 4% through 2021.
The global oligonucleotide synthesis market was valued at $1,561.6 million in 2018 and is expected to witness a growth of 10.45% from 2019 to 2026 and reach $3,401.3 million by 2026. The global RNA therapeutics market is estimated to reach $17 billion by 2027.
The pharmaceutical sector is one of the most valuable in the UK economy, contributing £21 billion in exports in 2020 and in manufacturing the highest gross added value (GVA) per employee across major European nations. There is an opportunity for the UK to take a leading position in the commercialisation at scale of nucleic acid therapies.
Until the recent National Institute for Health and Care Excellence (NICE) approval for use of Inclisiran to treat hypercholesterolemia by the NHS these therapies were largely focused on treating rare diseases with limited patient populations. This resulted in manufacturing at small scale only.
Moving forward nucleic acid therapies present unique manufacturing challenges that need to be solved, if they are to be scaled and delivered to large numbers of patients.
Data sharing
This competition is operated by Innovate UK.
Innovate UK is directly accountable to you for its holding and processing of your information, including any personal data and confidential information. Data is held in accordance with our own policies. Accordingly, Innovate UK will be data controllers for personal data submitted during the application. Innovate UK’s Privacy Policy is accessible here.
Innovate UK complies with the requirements of GDPR, and is committed to upholding the data protection principles, and protecting your information. The Information Commissioner’s Office also has a useful guide for organisations, which outlines the data protection principles.Find a project partner
If you want help to find a project partner, contact the Innovate UK KTN.
Support for SMEs from Innovate UK EDGE
If you receive an award, you will be contacted about working with an innovation and growth specialist at Innovate UK EDGE. This service forms part of our funded offer to you.
These specialists focus on growing innovative businesses and ensuring that projects contribute to their growth. Working one-to-one, they can help you to identify your best strategy and harness world-class resources to grow and achieve scale.
We encourage you to engage with Innovate UK EDGE, delivered by a knowledgeable and objective specialist near you.Next steps
If you are successful with this application, you will be asked to set up your project.
You must follow the unique link embedded in your email notification. This takes you to your IFS Set Up portal, the tool that Innovate UK uses to gather necessary information before we can allow your project to begin.
You will need to provide:
- the name and contact details of your project manager and project finance lead
- a redacted copy of your bank details
- a collaboration agreement
- an exploitation plan
In order to process your claims, we need to make sure that the bank details you give to us relate to a UK high street bank that is regulated by the Prudential Regulation Authority (PRA). The account must have a BACS clearing facility and be in the same company name as your application.
If you have any doubts that your bank account will not meet Innovate UK's funding criteria, you can use the sort code checker. If you input the sort code and find a tick next to the ‘BACS Direct Credit payments can be sent to this sort code’, this will give you an indication that the bank account you hold is acceptable.
Finance checks
We will carry out checks to make sure you are an established company with access to the funds necessary to complete the project.
You must check your IFS portal regularly and respond to any requests we have sent for additional information to avoid any delays.
Failure to complete project setup may result in your grant offer being withdrawn.
Your Grant offer letter (GOL)
Once you have successfully completed project setup, we will issue your GOL.
The GOL will be made available on your IFS portal. You will need to sign and upload this before you start your project.
Your GOL will show the start date for your project, do not start your project before this date. Any costs incurred before your start date cannot be claimed as part of your grant.
If your application is unsuccessful
If you are unsuccessful with your application this time, you can view feedback from the assessors. This will be available to you on your IFS portal following notification.
Sometimes your application will have scored well, and you will receive positive comments from the assessors. You may be unsuccessful as your average score was not above the funding threshold or your project has not been selected under the portfolio approach if this is applied for this competition.
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