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Rapid Bioprocess Development

Rapid Bioprocess Development

Objective

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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Coordinator

UNIVERSITY OF NEWCASTLE UPON TYNE

Address

Kings Gate
Ne1 7ru Newcastle Upon Tyne

United Kingdom

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 819 863,64

Participants (8)

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ALCYOMICS LTD

United Kingdom

EU Contribution

€ 273 287,88

RISE ACREO AB

Sweden

EU Contribution

€ 527 318,64

CHR. HANSEN A/S

Denmark

EU Contribution

€ 290 081,88

DANMARKS TEKNISKE UNIVERSITET

Denmark

EU Contribution

€ 580 163,76

FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED

United Kingdom

EU Contribution

€ 273 287,88

LINKOPINGS UNIVERSITET

Sweden

EU Contribution

€ 527 318,64

SANOFI-AVENTIS DEUTSCHLAND GMBH

Germany

EU Contribution

€ 249 216,48

TECHNISCHE UNIVERSITAT BERLIN

Germany

EU Contribution

€ 498 432,96

Project information

Grant agreement ID: 643056

Status

Closed project

  • Start date

    1 January 2015

  • End date

    31 December 2018

Funded under:

H2020-EU.1.3.1.

  • Overall budget:

    € 4 038 971,76

  • EU contribution

    € 4 038 971,76

Coordinated by:

UNIVERSITY OF NEWCASTLE UPON TYNE

United Kingdom