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Biorapid

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Rapid Bioprocess Development

Reducing lead times of new medicinal drugs to the market by reducing process development and clinical testing timeframes is a critical driver in increasing European (bio)pharmaceutical industry competitiveness. Despite new therape... ver más

31/12/2018

UNEW

4M€

Presupuesto del proyecto: 4M€

Líder del proyecto

UNIVERSITY OF NEWCASTLE UPON TYNE No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Ver 10 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2018-12-31

MSCA-ITN-2014-ETN: Marie Skłodowska-Curie Innovative T... Scope:European Training Networks (ETN)

I+D

Cerrada hace 10 años

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Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

10 Participantes

UNEW

819.86K€ | Lider

ESCORXADOR COMARCAL DEL MOIA...

469.19K€ | Participante

TECHNICAL UNIVERSITY OF DENM...

580.16K€ | Participante

CHR. HANSEN

290.08K€ | Participante

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Duración del proyecto: 48 meses Fecha Inicio: 2014-12-18
Fecha Fin: 2018-12-31

Líder del proyecto

UNIVERSITY OF NEWCASTLE UPON TYNE No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 4M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto Reducing lead times of new medicinal drugs to the market by reducing process development and clinical testing timeframes is a critical driver in increasing European (bio)pharmaceutical industry competitiveness. Despite new therapeutic principles (e.g. the use of pluripotent stem cells, regenerative medicine and treatments based on personalised medicine or biosimilars) or regulatory initiatives to enable more efficient production, such as Quality by design (QbD) with associated Process Analytical Technology (PAT) tools , the slow progress in the development of new bioactive compounds still limits the availability of cheap and effective medicines. In addition, the competitiveness of European (bio)pharma industry is impacted by the unavailability of suitably trained personnel. Fundamental changes in the education of scientists have to be realised to address the need for changes in the traditional ‘big pharma’ business model and the focus on ‘translational medicine – more early stage clinical trials with patients, more external innovation and more collaboration’ . These changes in education should be based on combining cutting-edge science from the early stage of product development through to manufacturing with innovation and entrepreneurship as an integral part of the training. The Rapid Bioprocess Development ITN, employing 15 ESRs, brings together industrialist and academic experts with its main aim to address this critical need by developing an effective training framework in rapid development of novel bioactive molecules from the very early stages of potency and efficacy testing to the biomanufacturing process characterisation and effective monitoring. The main focus of the research is on oncology related proteins and recombinant proteins to be used in diabetes treatment, although the resulting monitoring and modelling methods will be applicable to other bioactive molecule process development as demonstrated by validation on a range of relevant bioactives.

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