Chemically synthesised novel compounds for the stabilisation of biologics

Project Information

ExtremoChem

Grant agreement ID: 744677

DOI

10.3030/744677

Project closed

EC signature date 9 December 2016

Start date 1 December 2016

End date 31 March 2017

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

EXTREMOCHEM LDA
Portugal

Periodic Reporting for period 1 - ExtremoChem (Chemically synthesised novel compounds for the stabilisation of biologics)

Reporting period: 2016-12-01 to 2017-03-31

Summary of the context and overall objectives of the project

ExtremoChem proposes a novel protein stabilizer against aggregation and degradation of therapeutic proteins. PROTsteady is a universal stabilizer against any of environmental stresses, effective at any concentration. The compounds are integrated seamlessly into mAb’s processing steps/formulations, maintaining the structural integrity of the APIs. The key objectives are to prove the improvement of mAbs stability at the industrial scale and validate our compounds safety and potency in the drugs.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Throughout the duration of the Phase I project, ExtremoChem reviewed the product development plan, secured partners for further product development, expanded their knowledge of the biopharmaceutical market and established a commercialisation strategy. Series of stability studies with 14 commercially available biopharmaceuticals were performed, identifying the best performance compounds for each target biopharmaceutical at different environment stresses. The Phase 1 feasibility assessment established that a development plan for the PROTsteady product is technically and commercially viable, and that implementation of an industrialisation and commercialisation plan should be pursued. SME Instrument Phase 2 funding could provide the correct amount of funding and support to allow the stated activities to be implemented successfully.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

PROTsteady can contribute to lower biopharmaceuticals’ costs, including biosimilar products, making them better accessible to almost 3 million sufferers of rheumotoid arthritis, 5 million people with cancer and 3.7 million people with psoriasis in Europe. PROTsteady will therefore contribute to a sustainable and innovative healthcare system in Europe by reducing the large medical and social costs caused by these common diseases.

ExtremoChem lab