Funding competition UK and Canada biomanufacturing innovations in cell and gene therapies

A collaborative opportunity with the National Research Council of Canada on process improvement in biomanufacturing of gene and cell therapies

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Competition sections

Description

Innovate UK has partnered with The National Research Council of Canada (NRC) for this funding opportunity aimed at UK SMEs.

This competition aims to identify UK partners who will bring innovative solutions to support and collaborate with the NRC Challenge Program in Health and Disruptive Technologies for Cell and Gene Therapy.

We are specifically looking for projects in the following 2 areas:

  1. Process improvement for adeno-associated virus (AAV) based gene therapy.
  2. Deploy process analytical technologies to perfusion-enabled lentiviral vector manufacturing.

In applying to this competition you are entering into a competitive process. The competition closes at 11am UK time on the deadline stated.

Funding type

Grant

Project size

Your project’s total eligible costs must not exceed £128,000 over 24 months, of which up to 75% will be funded by this initiative.

Who can apply

State aid

This competition provides state aid funding under article 25 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 is unable to award grant funding to organisations meeting the condition known as undertakings in difficulty (UiD). However, as per the amendment on 2 July 2020 to the General Block Exemption regulation, we will provide funding to organisations that can prove they were not a UiD on the date of 31 December 2019 but became a UiD between 1 January 2020 and 30 June 2021. We will ask for evidence of this.

Any UK business claiming funding must be eligible to receive state aid at the time we confirm you will be awarded funding. If you are unsure please take legal advice. For further information see our general guidance.

Your project

Your project must:

  • have total eligible costs of up to £128,000
  • start by 1 May 2021
  • be up to 24 months in duration

Lead organisation

To lead a project your organisation must be either a:

  • UK registered micro, small or medium sized enterprise (SME)
  • catapult
  • charity
  • not for profit organisation

Your project must:

  • intend to exploit the results from or in the UK and Canada
  • carry out most of its project work in the UK

Academic institutions cannot lead.

Working in partnership with NRC

Before starting an application or being invited to join a project in the Innovation Funding Service, you must have established a partnership with an appropriate research team at NRC Canada.

If you do not name an NRC research partner, you will not be eligible for funding through this competition.

The Knowledge Transfer Network (KTN) will hold 2 information sessions on 14 October 2020 and

3 November 2020. At the sessions NRC researchers will explain the type of projects they are looking for. This will give you the chance to connect with the appropriate NRC counterparts before applying.

Further information on these sessions and the application process will be made available by the KTN.

You are expected to have attended the information sessions and have had discussions with NRC research partners before submitting a proposal.

You must include evidence of this preparatory work to establish a relationship and define the project scope in your proposal.

You do not need to invite your NRC partner into the Innovation Funding Service. Their costs will not count towards the total eligible project costs.

Project team

To collaborate with the lead organisation your organisation must:

  • be a UK registered SME, academic institution, catapult, charity, public sector organisation or research and technology organisation (RTO)
  • carry out most of its project work in the UK
  • intend to exploit the results from or in the UK and in Canada

If your application is a collaboration the lead and at least one other organisation must claim funding by entering their costs during the application.

Each partner organisation must be invited into the Innovation Funding Service by the lead to collaborate on a project. Once accepted, collaborators will be prompted to log in or create an account and enter their own project costs into the Innovation Funding Service.

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

Subcontractors

Subcontractors are allowed in this competition and must be selected through participant’s normal procurement process.

If an overseas subcontractor is selected, a case must be made as to why no UK-based subcontractor can be used including a detailed rationale, evidence of UK companies that have been approached and reasons why they were unable to do so. We would expect subcontractor costs to be justified and appropriate to the total eligible project costs. A cheaper cost is not deemed as a sufficient reason to use an overseas subcontractor.

Multiple applications

Any one SME, catapult, charity or not for profit organisation can lead on one application and collaborate in a further 2 applications.

If an SME, catapult, charity or not for profit organisation is not leading an application, it can collaborate in up to 3 applications.

An academic institution can collaborate in up to 3 applications.

Previous applications

You cannot use a previously submitted application to apply for this competition.

We will not award you funding if you have:

Funding

A total of up to £290,000 is allocated to fund 3 innovation projects in this competition. Your total grant funding must not exceed £96,000 This is regardless of the individual partners’ grant claims.

If your organisation’s work on the project is mostly commercial or economic, your funding request must not exceed the limits below. These limits apply even if your organisation normally acts non-economically.

For feasibility studies and 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 experimental development projects which are nearer to market, you could get funding for your eligible project costs of:

  • up to 45% if you are a micro or small organisation
  • up to 35% if you are a medium-sized organisation
  • up to 25% if you are a large organisation


The research organisations in your consortium undertaking non-economic activity as part of the project could get funding for your eligible project costs of:

  • up to 100% if you are a Catapult, RTO or not for profit organisation
  • up to 80% of full economic costs (FEC) if you are an academic organisation

The following specific terms and conditions will apply to this competition:

  1. Projects can only receive a maximum of 75% of total eligible project costs with a maximum grant of £96,000.
  2. Overheads must be capped at 10% of total eligible project costs.
  3. Purchase of equipment valued at more than £8,000 excluding VAT is ineligible for this call.

Overheads

Overheads include both indirect and direct costs.Indirect overhead costs are costs that cannot be attributed to any specific business activity or project but are necessary for the business to function. For example, insurance, telephone, management salaries.

Direct overhead costs are costs incurred in the undertaking of the project, and may include consumable materials and supplies, equipment rentals, rent & utilities. For example, facility or equipment rental costs required specifically for the execution of the project.

Successful applicants will be required to submit calculations for claiming direct and indirect overheads for review by our project finance team. This is so we can assess the appropriateness of the overhead value you are claiming and ensure that it does not exceed 10% of the total eligible costs for the project.

Your proposal

The aim of this competition is to support improvements in biomanufacturing for cost effective gene and cell-based therapies.

Your project must include teams from the UK and Canada’s National Research Council to develop solutions to address one of these two areas:

  1. Process improvement for adeno-associated virus (AAV) based gene therapy.
  2. Deploy process analytical technologies to perfusion-enabled lentiviral vector manufacturing.

Process improvement for adeno-associated virus (AAV) based gene therapy

Your proposal must:

  • demonstrate economical viability by coupling your proposal to more cost-effective downstream processing options than what is currently available
  • be based on transient transfection, developing improvement of serum free media or processes to increase AAV upstream yields
  • develop faster in-line, online, at-line or off-line process analytical assays to support process development
  • develop more cost effective, robust and scalable AAV particle separation methods (preferably chromatography based).

Deploy process analytical technologies to perfusion-enabled lentiviral vector (LV) manufacturing

You will have access to the perfusion-enabled high yield LV production process developed at NRC.

Your proposal must show how you will develop and deploy complementary in-line monitoring technologies for real time process characterisation using:

  • capacitance frequency scanning (Aber Instruments)
  • multi-wavelength fluorometry (NRC technology)
  • Raman spectroscopy including analysis algorithms

We are looking to fund a portfolio of projects, across the above themes.

Specific themes

Your project must focus one or more of the following:

  1. Upstream process intensification for AAV production based on transient transfection using HEK293 cells (must be with NRC’s HEK293 cells) in suspension culture and serum free medium
  2. Development of faster analytic assays for AAV to support process improvement
  3. New cost-effective technology for AAV downstream processing
  4. Robust and scalable (preferentially chromatography based) empty/full AAV particle separation methods
  5. Semi-fully continuous downstream processing, promising higher throughput and reduced costs for AAV.
  6. Process analytical technologies for lentiviral vector manufacturing amenable to production in perfusion

Research categories

We will fund feasibility studies, industrial research and experimental development projects as defined in the general guidance.

Projects we will not fund

We will not fund projects that:

  • are fundamental research
  • do not include at least one area covered under specific themes
  • are new cell line development
  • are isolation or engineering of new serotypes of AAV
  • are gene therapy projects aiming at developing treatments for specific disease
  • are proof of concepts in animal models
  • are clinical trials

14 October 2020
Online Information session
26 October 2020
Competition opens
3 November 2020
Online information session
23 December 2020 11:00am
Competition closes
2 February 2021
Invite to interview
15 February 2021
Interview panel
26 February 2021
Applicants notified

Before you start

You must read the guidance on applying for a competition on the Innovation Funding Service before you start.

Innovate UK is unable to award grant funding to organisations meeting the condition known as undertakings in difficulty (UiD).

Interviews

If your written application is successful you will be invited to attend an interview, over an on-line platform, where you must give a presentation. Your interview will take place during the week commencing 15 February 2021.

Before the interview, by the deadline stated in the invitation email, you:

  • must send a list of who will attend the interview
  • must send your interview presentation slides
  • can send a written response to the assessors’ feedback

List of attendees

Agree the list with your consortium. Up to 6 people from your project can attend, ideally one person from each organisation. They must all be available on all published interview dates. We are unable to reschedule slots once allocated.

Presentation slides

Your interview presentation must:

  • use Microsoft PowerPoint
  • be no longer than 10 minutes
  • have no more than 10 slides
  • not include any video or embedded web links

You cannot change the presentation after you submit it.

Written response to assessor feedback

This is optional and is an opportunity to answer the assessors’ concerns. It can:

  • be up to 2 A4 pages in a single PDF or Word document
  • include charts or diagrams

Interview

After your presentation the panel will spend 20 minutes asking questions. You will be expected to answer based on your application form and the assessor feedback from the written stage.

What we will ask you

The application is split into three sections:

  1. Project details.
  2. Application questions.
  3. Finances.

1. Project details

This section provides background 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.

Research category
Select the type of research you will undertake.

Equality, diversity and inclusion

We collect and report on equality, diversity and inclusion (EDI) data to address under-representation in business innovation and ensure equality, diversity and inclusion across all our activities.

You must complete this EDI survey and then select yes in the application question. The survey will ask you questions on your gender, age, ethnicity and disability status. You will always have the option to ‘prefer not to say’ if you do not feel comfortable sharing this information.

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 and the work you have undertaken with your chosen NRC research partner that has enabled you to meet the competition scope

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.

2. 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
  • 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 must submit one appendix to support your answer. It must be a PDF, can be up to 2 A4 pages long and no larger than 10MB in size. 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, particularly in the light of any continuing COVID-19 restrictions
  • 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
  • the preparatory work you have undertaken to establish a relationship with your chosen NRC research partner
  • any roles you will need to recruit for taking into account the impact of COVID-19 restrictions on the team structure
  • the NRC research partner you have chosen to work with and the preparatory work you have undertaken to establish a relationship with them

You must submit one appendix describing the skills and experience of the main people working on the project to support your answer. It must be a PDF, can be up to 4 A4 pages long and no larger than 10MB in size.. 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
  • the impact COVID-19 has had on businesses or sectors that are a focus of your project

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, particularly if COVID-19 has changed market dynamics
  • 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, taking into account the possible impact of further COVID-19 restrictions

You must submit a project plan or Gantt chart as an appendix to support your answer. It must be a PDF, can be up to 2 A4 pages long and no larger than 10MB in size. 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
  • 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, can be up to 2 A4 pages long and no larger than 10MB in size.. 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 subcontractor costs and why they are critical to the project

3. Finances

Each organisation in your project must complete their own project costs, organisational details and funding details in the application. 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

NRC is developing transformative technologies and implementing innovative collaborative models to create a coordinated Canadian value chain for the development and delivery of safe, accessible and affordable engineered cell and gene therapies.

A major component of this effort is process improvement in biomanufacturing of gene and cell therapies.

Contact us

If you need assistance using the Innovation Funding Service, email support@innovateuk.ukri.org or call the Innovate UK competition helpline on 0300 321 4357.

Our phone lines are open from 9am to 11:30am and 2pm to 4:30pm, Monday to Friday (excluding bank holidays).

Find a project partner

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

Enterprise Europe Network

If you are a UK SME and successful in receiving an award, you will be contacted by your local Enterprise Europe Network (EEN) Innovation Advisor. They act on behalf of Innovate UK to discuss the growth opportunities for your business.

They offer bespoke business support services to help you maximise your project and business potential. This service forms part of your Innovate UK offer under our commitment to help UK SMEs grow and scale.

Need help with this service? Contact us