H2020Докторантска мрежа2015–2018

Biorapid · Rapid Bioprocess Development

„Хоризонт 2020“ — Действия „Мария Склодовска-Кюри“

Период
2015-01-01 → 2018-12-31
Финансиране от ЕС
4 038 972 €
Участници
9
Схема
MSCA-ITN-ETN

Линиите свързват координатора с партньорите.

Накратко на български

Методите за бързо разработване на биоактивни молекули, като протеини за лечение на рак и диабет, се оптимизират чрез нови модели за мониторинг. Това съкращава времето за клинични тестове и производство, което прави лекарствата по-достъпни и евтини.

Този кратък обзор е генериран от изкуствен интелект

Кратко обяснение, генерирано от езиков модел по текста на CORDIS. Оригиналът е по-долу.

Резултати накратко

Rapid Bioprocess Development

Reducing lead times of medicinal drugs to the market by reducing process development and clinical testing timeframes is a critical driver in increasing EU (bio)pharmaceutical industry competitiveness. Despite new therapeutic principles or regulatory initiatives to enable more efficient production, the slow progress in the development of new bioactive compounds still limits the availability of cheap and effective medicines. The competitiveness of EU (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. Biorapid ITN brings together industrialist and academic experts 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.

Текст от CORDIS, на английски · Данни: CORDIS, © Европейски съюз

Цел на проекта

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.

Оригинален текст от CORDIS (на английски).

Участници

Връзки

Данни: CORDIS, © Европейски съюз