Chemically synthesised novel compounds for the stabilisation of biologics

Información del proyecto

ExtremoChem

Identificador del acuerdo de subvención: 744677

DOI

10.3030/744677

Proyecto cerrado

Fecha de la firma de la CE 9 Diciembre 2016

Fecha de inicio 1 Diciembre 2016

Fecha de finalización 31 Marzo 2017

Financiado con arreglo a

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

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

EXTREMOCHEM LDA
Portugal

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

Período documentado: 2016-12-01 hasta 2017-03-31

Resumen del contexto y de los objetivos generales del proyecto

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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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