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UK and Canada biomanufacturing innovations in cell and gene therapies

Overview:

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

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.

Innovate UK are specifically looking for projects in the following two areas:

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

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.

Open Date:

26/10/2020

Close Date:

23/12/2020

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

Innovate UK 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

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 two 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. Innovate UK 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 two applications.

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

An academic institution can collaborate in up to three applications.

A total of up to £290,000 is allocated to fund three 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 Innovate UK’s project finance team. This is so they 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.

Innovate UK 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

Cresco Innovation works with companies to develop and implement innovation strategies. We help client companies identify opportunities to develop new products and services, and then create a package of support to ensure that the idea is turned into a commercial reality.

Our services include securing grants (as a team we have raised around £40million over three years), business planning, IP advice, access to finance and funders, project management and IP commercialisation support.

We regularly act as the interface with the funding bodies and help clients ensure that their projects are properly managed to ensure the best outcome for all.

Call to find out more

If you’d like to know more about this competition, please give us a call on 01509 261182 and one of our team will be delighted to help you access this funding opportunity for your business.