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Chemically synthesised novel compounds for the stabilisation of biologics

Objective

Biologics are medical drugs produced using biotechnology, other than direct extraction from a native biological source. Many of biopharmaceutical products are subject to very strict production, storage and distribution requirements in order to preserve effectiveness and safety. Biopharmaceuticals stability is a key issue in assuring that these medicines maintain their quality, safety and full potency. Once potency is lost, it cannot be restored, this means the biologic is wasted.

ExtremoChem synthesises a line of novel compounds consisting of synthetic small organic molecules, from 8 to 12 carbons, that are able to stabilise proteins and other biological material by preventing their degradation under stressful conditions, such as higher or lower temperatures, pH, salinity, agitation under which they would otherwise degrade. eXtremochem is suitable for a wide range of proteins such as mAbs, vaccines, insulins, interferins and etc. But ExtremoChem currently focuses on mAbs, such as Humira (for rheumatoid arthritis) & Neupogen (for growth of white blood cells), since they present a high value market. The eXtremochem compounds improve the stability of molecules in the most critical purification stages and protects biologics, preventing aggregation and increasing production volume by 20%. Furthermore, eXtremochem enables long-term storage of thermally sensitive biologics without the need for cold chain, thus bringing significant savings to biopharmaceuticals – 6.5% of their revenues.

The Phase 1 project will allow ExtremoChem to evaluate the medicines’ degradation under the presence of the small organic molecules through several stabilization tests, prepare a feasible industrial scale-up plan, plan a sound Ph 1 clinical trial, elaborate the business scale up, and size the reachable market and a reliable market share. Within the overall project, ExtremoChem aims to: obtain the clinical validation and sign at least one commercial agreement.

Fields of science (EuroSciVoc)

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Programme(s)

Multi-annual funding programmes that define the EU’s priorities for research and innovation.

Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

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.

SME-1 - SME instrument phase 1

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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-SMEInst-2016-2017

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Coordinator

EXTREMOCHEM LDA
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.

€ 50 000,00
Address
Estrada Municipal 528, 1
7040-220 Igrejinha
Portugal

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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
Continente Alentejo Alentejo Central
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
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.

€ 71 429,00
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