Life Sciences Innovative Manufacturing Fund (LSIMF) is sponsored by UK Government. The Life Sciences Innovative Manufacturing Fund (LSIMF) is a capital grants fund that aims to build resilience for future health emergencies and capitalize on the UK's world-leading research and development capabilities.

It will enhance and accelerate affordable access to mature, new, and emerging Life Sciences products for both pandemic and non-pandemic scenarios. The fund is open to applications for MHRA-licenced medicines, medical and diagnostic devices, and products in development where approval to market or manufacture the medicine or device in the UK is intended to be sought for commercial scale-up.

Life Sciences Innovative Manufacturing Fund (LSIMF): application guide - GOV.UK This publication is available at https://www. gov.uk/government/publications/life-sciences-innovative-manufacturing-fund-lsimf/life-sciences-innovative-manufacturing-fund-lsimf-application-guide This guide sets out what the Life Sciences Innovative Manufacturing Fund is and how to apply for funding.

About the Life Sciences Innovative Manufacturing Fund ( LSIMF ) The LSIMF will be UK and sector wide and will provide capital grants for investments in the manufacture of: Human medicines (this includes both the manufacture of active pharmaceutical ingredients ( API ) / drug substance and finished product / drug product). Medical diagnostics – for both disease identification and monitoring.

MedTech products – all types of medical devices related to human health. The fund will remain open until all the funding has been allocated. Applicants will be prioritised based on their alignment to the fund’s objectives: To increase UK health resilience by strengthening the UK’s manufacturing capacity and capability.

We define health resilience as the UK’s ability to withstand and recover from health emergencies such as pandemics, long-term healthcare challenges and system shocks such as supply chain disruption. To create economic opportunity through investments that will make a substantial contribution to Gross Value Added ( GVA ) and provide high-wage, high-skilled jobs around the UK.

How your application is assessed (eligibility) To be eligible for the fund, your company must be a: Wholly private sector business. Product developer, contract development manufacturing organisation, or a generics manufacturer.

To be eligible for the fund, your project must: Have a total cost (capital and non-capital costs) of at least £8 million Be primarily a capital investment Be a single company investment (as opposed to forming a partnership between companies or other types of organisations) Require only the amount of grant requested to proceed.

For example, without the specific amount of funding you are requesting your project wouldn’t go ahead or go ahead at a smaller scale, go ahead overseas or would be significantly delayed (3 years or more) Be a manufacturing project for the manufacture of: Human medicines (this includes both the manufacture of active pharmaceutical ingredients ( API ) / drug substance and finished product / drug product).

Medical diagnostics – for both disease identification and monitoring MedTech products – all types of medical devices related to human health.

The fund is open to applications for MHRA -licenced medicines, medical and diagnostic devices registered with the MHRA , and products in development where approval to market or manufacture the medicine or device in the UK is intended to be sought for commercial scale-up, for example a manufacturing project for clinical trials or investigational studies.

Manufacturing facilities are required to work to Good Manufacturing Practice (GMP) and the facility be intended to support clinical and/or commercial manufacture of API or drug product. Manufacturers of medicinal diagnostics and medical devices must confirm that their device meets or intends to meet the requirements of the Medical Devices Regulations 2002.

Projects that are not eligible Projects relating to the following are not eligible for funding from LSIMF : Nutritional supplements or vitamins Raw ingredients (e. g solvents, buffers and cleaning agents) The production of single-use consumables that are not integrated into a larger product (e. g manufacturing syringes independently from diagnostic kits) Secondary packaging for products or materials (e.

g package inserts, labelling and boxes). The LSIMF application process has 3 sections. Section 1: Expression of Interest (EOI) We will use the EOI to evaluate your basic eligibility and identify projects that align with LSIMF ’s objectives.

Eligible projects will be invited to the next stage. Section 2: Health resilience assessment We will assess the health resilience benefits of your project: You will need to describe the health resilience benefits of your project. This stage is assessed by a panel of cross-government officials.

You will be required to give a brief presentation on the health resilience benefits of your project, followed by a question and answer session. The interview will be hosted by a panel of independent manufacturing experts who will further assess your project’s health resilience benefits.

Section 3: Financial and economic assessment If you are successful following the health resilience assessment, you will be invited to complete application form 2. Questions will cover eligibility, company and project specifics and financial information, markets and economic impacts and project risks​. You will be required to provide further documentation to evidence your company’s financial position, eligibility and project viability.

We will assess whether your grant request offers good value for money, ensure compatibility with subsidy control regulations, validate what would happen without a grant, and confirm the project’s deliverability, employment outputs and your ability to finance it. You may be required to provide further documentation to evidence your company’s financial position, eligibility and project deliverability.

Submit an Expression of Interest You can submit your EOI via the Find a Grant page . Your EOI will be used to assess your project’s eligibility and can be submitted at any time whilst the fund is open. If your project is deemed eligible, you will be invited to submit an application.

Table 1: Expected timeframes LSIMF opens for EOIs and will continue to accept EOIs on a rolling basis. Applications will be assessed in quarterly rounds until all funding has been allocated. Details will be published on the Find-A-Grant page .

First grants awarded to successful projects. LSIMF will remain open until all of the funding has been allocated. Please note that the timeframes may be subject to change.

See the Find a grant service terms and conditions for more information. For any queries related to the fund or your application, please contact LSIMF @officeforlifesciences. gov.uk .

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