Rapid Bioprocess Development - What is it all about?

How do you develop new biopharmaceuticals faster, safer, better? BIORAPID provides a generic platform solution by exploiting mathematical modelling. We are 15 international PhD students working in nine universities and biopharmaceutical companies all over Europe. This Marie Skłodowska-Curie project investigates rapid screening, better bioprocess development, efficient process scale up and advanced monitoring tools in order to produce new biopharmaceuticals safer, faster and better!!! Website http://www.bio-rapid.eu twitter https://twitter.com/BioRapidSci Facebook https://www.facebook.com/biorapid.scientists The authors gratefully acknowledge the financial support from the EU-Horizon 2020 Marie Skłodowska-Curie actions (MSCA) ITN project BIORAPID (no. 643056).

BioRAPID

(The Rapid Bioprocess Development ITN)

Objective

The main objective of this ambitious H2020 ITN is to establish a pan-European training network providing essential training to Early Stage Researchers (ESRs) in methods of rapid bioprocess development. The BIORAPID consortium, consisting of industrial and academic partners, will provide the ESRs with advanced training in skills that should enable them to integrate directly into the European biopharmaceutical industry, thereby increasing its competitiveness worldwide.

Biorapid uniquely brings the studies on efficacy, toxicity, immunogenicity and hypersensitivity into the process development by using new predictive modelling tools (as PAT tools) with the aim to support early screening of potential drug candidates. This provides a comprehensive scientific training to the ESRs in this area as well as providing the European biopharmaceutical industry with a valuable framework for future rapid bioprocess development.

Background

Reducing lead times of new medicinal drugs to the market by reducing process development and clinical testing timeframes is a critical driver in increasing the competitiveness of the European (bio)pharmaceutical industry. Despite new therapeutic principles (e.g. the use of pluripotent stem cells, regenerative medicine and treatments based on personalized 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 the 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 Project

Early proof of manufacturability based on rigorous product/process characterization (with concomitant early failure of weak products) and rapid process development will ensure speed-to-market that will maximally exploit the period of patent protection before competitive bio-similar products pose a challenge to business success. To address this new way of thinking the research focus is to train a new generation of researchers with competencies in all stages of commercial biopharmaceutical process development through the following program of interrelated research projects within 7 coherent Work Packages.

This bioprocess development framework is achieved in conjunction with ITN partners: Newcastle University (UNEW), Danmarks Tekniske Universitet (DTU), Technische Universität Berlin (TUB), Linköping Universitet (LIU), Sanofi Aventis Deutschland GmbH (SAN), Chr Hansen A/S (CHN), Acreo Swedish ICT AB (Acreo), Alcyomics (ALC) and Fujifilm Diosynth Biotechnologies (Fuji).

For more information please visit the BioRAPID project website.

Kontakt

Krist V. Gernaey
Professor
DTU Kemiteknik
45 25 29 70