Chemically synthesised novel compounds for the stabilisation of biologics

Informazioni relative al progetto

ExtremoChem

ID dell’accordo di sovvenzione: 744677

DOI

10.3030/744677

Progetto chiuso

Data della firma CE 9 Dicembre 2016

Data di avvio 1 Dicembre 2016

Data di completamento 31 Marzo 2017

Finanziato da

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

Costo totale

€ 71 429,00

Contributo UE

€ 50 000,00

Coordinato da

EXTREMOCHEM LDA
Portugal

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

Periodo di rendicontazione: 2016-12-01 al 2017-03-31

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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