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Intelligent Live Cell Analysis [iLCA] to transform disease management through faster, and more regulatory robust, discovery, manufacture and monitoring of biologic drugs & cell therapies

Project description

A disruptive platform breathing fresh life into the cell line development process

Biologic medicines offer new therapy options for several diseases such as cancer. To develop and produce them entails a costly, lengthy and resource-intensive Cell Line Development (CLD) process whereby a high producing clone is selected from a cell line. Currently, clone selection is based on their product titer which can cause complications later in production. The EU-funded iLCA project will validate the technical and economic performance of its innovative technology solution for CLD - an intelligent Live Cell Analysis platform which provides end-users with a manufacturability index containing detailed information on their clones. The project aims to deliver an industry-endorsed analytical solution for the CLD process.

Objective

The detailed analysis of live cells, as shed elements of a human disease process, cell therapies themselves or as factories for the production of biologic drugs, is attracting intense focus globally from diverse companies in automation, imaging, diagnostics and manufacturing. This proposal is made on behalf of a consortium of 3 European SME’s to support the validation and preparation for commercial take-up of the market entry application, Cell Line Development [CLD], of a new transformative technology at the forefront of these areas and is ideally suited for cell line development, antibody discovery, gene editing, cell therapy, antibody engineering and ex-vivo diagnostic workflows. Each workflow provides a dramatic increase in insight, control, speed and cost, ultimately resulting in faster, cheaper and more regulatory robust medicines for European patients. Biologic drugs are large in size and are manufactured from a single cell selected following an expensive, relatively crude and time consuming process - Cell Line Development. Our technology can select the 'Top' cell using a detailed analysis of the critical quality attributes along with providing complete image recording and documentation of the growth from a single cell [regulatory requirement]. This cell selection and control is essential as all resulting master and working cell banks are used over the entire life‐cycle of the marketed product that can last multiple decades. This FTI funding will enable market entry and validation & support external fundraising for the wider penetration of the global drug discovery, Cell therapy & ex-vivo diagnostic markets. This is a potentially transformative technology platform in a very large market with 1 current aggressively funded US competitor and our success will ensure competition, continued innovation and most importantly cheaper medicines for European patients.

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Programme(s)

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Topic(s)

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Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

IA - Innovation action

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-EIC-FTI-2018-2020

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Coordinator

VALITACELL LTD
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 135 667,75
Address
FOSTERS AVE. - MOUNT MERRION, BLACKROCK
V94 DUBLIN 2
Ireland

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Ireland Eastern and Midland Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 622 382,50

Participants (2)

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