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Biorapid

Rapid Bioprocess Development

Total Cost €

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EC-Contrib. €

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Partnership

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 Biorapid project word cloud

Explore the words cloud of the Biorapid project. It provides you a very rough idea of what is the project "Biorapid" about.

entrepreneurship    efficacy    patients    treatment    innovation    recombinant    cutting    personalised    efficient    molecule    fundamental    times    bioprocess    framework    applicable    driver    potency    stage    medicine    ing    pharma    esrs    slow    medicinal    itn    cheap    stages    treatments    realised    experts    monitoring    15    bioactive    limits    timeframes    regulatory    training    big    industrialist    regenerative    oncology    suitably    business    despite    validation    molecules    characterisation    bioactives    industry    drugs    analytical    pharmaceutical    compounds    critical    edge    quality    employing    translational    rapid    competitiveness    impacted    trials    trained    proteins    medicines    biosimilars    tools    stem    brings    integral    combining    therapeutic    manufacturing    demonstrated    education    model    reducing    pat    unavailability    external    market    progress    biomanufacturing    clinical    diabetes    academic    principles    scientists    bio    science    qbd    cells    pluripotent   

Project "Biorapid" data sheet

The following table provides information about the project.

Coordinator
UNIVERSITY OF NEWCASTLE UPON TYNE 

Organization address
address: KINGS GATE
city: NEWCASTLE UPON TYNE
postcode: NE1 7RU
website: http://www.ncl.ac.uk/

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country United Kingdom [UK]
 Project website http://www.bio-rapid.eu/
 Total cost 4˙038˙971 €
 EC max contribution 4˙038˙971 € (100%)
 Programme 1. H2020-EU.1.3.1. (Fostering new skills by means of excellent initial training of researchers)
 Code Call H2020-MSCA-ITN-2014
 Funding Scheme MSCA-ITN-ETN
 Starting year 2015
 Duration (year-month-day) from 2015-01-01   to  2018-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    UNIVERSITY OF NEWCASTLE UPON TYNE UK (NEWCASTLE UPON TYNE) coordinator 819˙863.00
2    DANMARKS TEKNISKE UNIVERSITET DK (KGS LYNGBY) participant 580˙163.00
3    LINKOPINGS UNIVERSITET SE (LINKOPING) participant 527˙318.00
4    RISE ACREO AB SE (KISTA) participant 527˙318.00
5    TECHNISCHE UNIVERSITAT BERLIN DE (BERLIN) participant 498˙432.00
6    CHR. HANSEN A/S DK (HOERSHOLM) participant 290˙081.00
7    ALCYOMICS LTD UK (NEWCASTLE UPON TYNE) participant 273˙287.00
8    FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED UK (BILLINGHAM) participant 273˙287.00
9    SANOFI-AVENTIS DEUTSCHLAND GMBH DE (FRANKFURT AM MAIN) participant 249˙216.00

Map

 Project 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.

 Deliverables

List of deliverables.
Two complete case studies (i) a manufacturing system for recombinant biopharmaceutical, and (ii) a manufacturing system for a drug compound Documents, reports 2020-01-21 11:30:51
Oscillation effect/product quality methodology tested on model system Other 2020-01-21 11:30:51
Immune/media sensors tested in industrial conditions Documents, reports 2020-01-21 11:30:51
Soft sensor system developed and tested in industrial conditions Documents, reports 2020-01-21 11:30:51
PhD theses complete Documents, reports 2020-01-21 11:30:51
DoE and optimal design validated on industrial case study Demonstrators, pilots, prototypes 2020-01-21 11:30:51
Modelling framework for rapid screening of toxicity/immunogenicity of bioactives Other 2020-01-21 11:30:51
PAT system design under uncertainty: practical validation on a lab-scale recombinant yeast fermentation Documents, reports 2020-01-21 11:30:51
DoE and optimal design tested on a model system Other 2020-01-21 11:30:51
Population heterogeneity methodology tested on model system Other 2020-01-21 11:30:51
Overall framework for rapid screening, process development and monitoring Documents, reports 2020-01-21 11:30:51
General framework for data representation with small batch numbers, across process scales Documents, reports 2020-01-21 11:30:51
Rapid bioprocess development strategy for diverse biomolecule structures Documents, reports 2020-01-21 11:30:51
Methodology to investigate population heterogeneity formulated Documents, reports 2020-01-21 11:30:50
BioRapid mid-term and final conferences Other 2020-01-21 11:30:49
Methodology to investigate oscillation effects on product quality Documents, reports 2020-01-21 11:30:50
Framework for PAT system design under uncertainty Other 2020-01-21 11:30:50
Dissemination plan formally approved Documents, reports 2020-01-21 11:30:50
Report on the most appropriate modelling methods for prediction of processing routes Documents, reports 2020-01-21 11:30:50
Report on most appropriate modelling approaches for the general bioprocess monitoring framework Documents, reports 2020-01-21 11:30:50
Two soft sensors adapted to impurity control of chromatography Documents, reports 2020-01-21 11:30:49
Predictive models for the behaviour of two bioactive molecules in response to processing conditions Documents, reports 2020-01-21 11:30:50
Report on appropriate modelling methodologies for soft sensor development for model process of partners Documents, reports 2020-01-21 11:30:50
Project website and webinar/e-seminar software setup Other 2020-01-21 11:30:49

Take a look to the deliverables list in detail:  detailed list of Biorapid deliverables.

 Publications

year authors and title journal last update
List of publications.
2018 Robert Spann, Jens Glibstrup, Klaus Pellicer-Alborch, Stefan Junne, Peter Neubauer, Christophe Roca, David Kold, Anna Eliasson Lantz, Gürkan Sin, Krist V. Gernaey, Ulrich Krühne
CFD predicted pH gradients in lactic acid bacteria cultivations
published pages: , ISSN: 0006-3592, DOI: 10.1002/bit.26868
Biotechnology and Bioengineering 2020-01-21
2018 Robert Spann, Christophe Roca, David Kold, Anna Eliasson Lantz, Krist V. Gernaey, Gürkan Sin
A probabilistic model-based soft sensor to monitor lactic acid bacteria fermentations
published pages: 49-60, ISSN: 1369-703X, DOI: 10.1016/j.bej.2018.03.016
Biochemical Engineering Journal 135 2020-01-21
2019 Kizhedath, A., Karlberg, M., Glassey, J
Cross interaction chromatography based QSAR model for early stage screening to facilitate enhanced developability of monoclonal antibody therapeutics
published pages: , ISSN: 1860-6768, DOI: 10.1002/biot.201800696
Biotechnology Journal 2020-01-21
2018 Emmanuel Anane, Annina Sawatzki, Peter Neubauer, Mariano Nicolas Cruz-Bournazou
Modelling concentration gradients in fed-batch cultivations of E. coli  - towards the flexible design of scale-down experiments
published pages: , ISSN: 0268-2575, DOI: 10.1002/jctb.5798
Journal of Chemical Technology & Biotechnology 2020-01-21
2016 Guerra, A, von Stosch, M, Glassey, J
Supervision Modelling Framework for Bioprocesses
published pages: , ISSN: , DOI:
Bioprocess XIII 2020-01-21
2018 Arathi Kizhedath, Simon Wilkinson, Jarka Glassey
Applicability of Traditional In Vitro Toxicity Tests for Assessing Adverse Effects of Monoclonal Antibodies: A Case Study of Rituximab and Trastuzumab
published pages: 30, ISSN: 2073-4468, DOI: 10.3390/antib7030030
Antibodies 7/3 2020-01-21
2016 Konakovsky, V, McCreath, G, Glassey, J
Which scale down model heuristics should we use in ambr bioreactors?
published pages: , ISSN: , DOI:
Bioprocess UK XIII 2020-01-21
2016 Karlberg, M, von Stosch, M, McCreath, G, Glassey, J
Early Bioprocess development using PAT approaches
published pages: , ISSN: , DOI:
ESBES 2020-01-21
2016 Kizhedath, A, Wilkinson S, Glassey J
Early toxicity prediction using hybrid-based modelling
published pages: , ISSN: , DOI:
Biorpocess UK XIII 2020-01-21
2018 Karlberg, M, Glassey, J:
Exploiting mAb structure characteristics for a directed QbD implementation in process development
published pages: , ISSN: , DOI:
ESBES Conference proceedings 2020-01-21
2016 Kizhedath A, Solovyova A, Glassey J
Detecting the Aggregation of Antibodies by Analytical Ultracentrifugation
published pages: , ISSN: , DOI:
Bioprocess XIII 2020-01-21
2018 Kizhedath, A, Wilkinson, S, Glassey, J
Hybrid modelling approaches for early stage screening of monoclonal antibodies based on safety for rapid mAb developability
published pages: , ISSN: , DOI:
ESBES Conference proceedings 2020-01-21
2015 Konakovsky, V, McCreath, G and Glassey J
Data augmentation of high-throughput bioprocesses by rapid streamlining algorithms
published pages: , ISSN: , DOI:
Biorpocess XII 2020-01-21
2017 Karlberg, M, von Stosch, M, Glassey, J
Exploiting mAb structure characteristics for a directed QbD implementation in process development
published pages: , ISSN: , DOI:
WCCE 2020-01-21
2018 Konakovsky, V, McCreath, G, Glassey, J
Using machine learning tools in bioprocess scale up when the number of batches is small
published pages: , ISSN: , DOI:
AICHE 2020-01-21
2018 Arathi Kizhedath, Simon Wilkinson, Jarka Glassey
Assessment of hepatotoxicity and dermal toxicity of butyl paraben and methyl paraben using HepG2 and HDFn in vitro models
published pages: , ISSN: 0887-2333, DOI: 10.1016/j.tiv.2018.12.007
Toxicology in Vitro 2020-01-21
2018 Guerra AC, Glassey J.
Machine learning in biopharmaceutical manufacturing
published pages: 62-65, ISSN: 1360-8606, DOI:
European Pharmaceutical Review 23(4) 2020-01-21
2018 Konakovsky, V, Andersen, M.G, Tajsoleiman, T, McCreath, G, Krühne, U, Glassey, J.
CFD in single-use bioreactors support scale-up in mammalian cell culture
published pages: , ISSN: , DOI:
ESBES Conference proceedings 2020-01-21
2017 Kizhedath, A, Wilkinson, S, Glassey, J.
Early adverse-effect prediction using hybrid-based modelling
published pages: , ISSN: , DOI:
WCCE 2020-01-21
2016 Kizhedath, A, Wilkinson, S, Glassey, J
Early toxicity prediction using hybrid-based modelling
published pages: , ISSN: , DOI:
ESBES 2020-01-21
2018 Kizhedath, A, Wilkinson, S, Glassey, J
Early stage adverse effect prediction for rapid screening and developability of monoclonal antibody therapeutics using a hybrid modelling framework
published pages: , ISSN: , DOI:
British Toxicology Society 2020-01-21
2018 Glassey J
Bioprocess development: moving through the scales with more confidence
published pages: , ISSN: , DOI:
Bioprocessing European Summit 2020-01-21
2016 Konakovsky, V, Sully, S, Slingsby, F, McCreath, G, Glassey, J
Scale down model characterization using Ambr 250 and SUB
published pages: , ISSN: , DOI:
BPI Europe 2020-01-21
2016 Kizhedath, A, Wilkinson, S, Glassey, J
Early toxicity prediction using hybrid-based modelling
published pages: , ISSN: , DOI:
EuroQSAR 2020-01-21
2017 Kizhedath, A., Glassey, J:
The importance of critical quality attributes in Quality by Design for rapid bioprocess development strategies
published pages: 48-50, ISSN: 1360-8606, DOI:
European Pharmaceutical Review 22(6) 2020-01-21
2017 Konakovsky, V, McCreath, G, Glassey, J
An industrial perspective on using ambr as scale down models in mammalian cell culture
published pages: , ISSN: , DOI:
ESACT 2020-01-21
2017 Micael Karlberg, Moritz von Stosch, Jarka Glassey
Exploiting mAb structure characteristics for a directed QbD implementation in early process development
published pages: 957-970, ISSN: 0738-8551, DOI: 10.1080/07388551.2017.1421899
Critical Reviews in Biotechnology 38/6 2020-01-21
2016 Konakovsky, V, McCreath, G and Glassey J:
Accelerated bioprocess characterization by data enrichment in scale-down models
published pages: , ISSN: , DOI:
Cell Culture Engineering 2020-01-21
2016 Guerra, A, von Stosch, M, Glassey, J
M3C in Mammalian Cell Cultures: Data Pre-processing Methods
published pages: , ISSN: , DOI:
ESBES 2020-01-21
2017 Karlberg, M, Kizhedath, A., von Stosch, M, Wilkinson, S, Glassey J
Exploiting mAb structure characteristics for rapid screening and a directed QbD implementation in process development
published pages: , ISSN: , DOI:
ACS Biot 2020-01-21
2018 Kizhedath, A, Wilkinson, S, Glassey, J
Assessment of hepatotoxicity and dermal toxicity of butyl paraben and methyl paraben using HepG2 and HDFn in vitro models
published pages: , ISSN: , DOI:
British Toxicology Society 2020-01-21
2018 Guerra, A, Dalton, J, Glassey, J
Soft-sensor platform for biopharmaceutical development and manufacturing
published pages: , ISSN: , DOI:
ESBES Conference proceedings 2020-01-21
2018 Martin Kögler, Andrea Paul, Emmanuel Anane, Mario Birkholz, Alex Bunker, Tapani Viitala, Michael Maiwald, Stefan Junne, Peter Neubauer
Comparison of time‐gated surface‐enhanced raman spectroscopy (TG‐SERS) and classical SERS based monitoring of Escherichia coli cultivation samples
published pages: 1533-1542, ISSN: 8756-7938, DOI: 10.1002/btpr.2665
Biotechnology Progress 34/6 2020-01-21
2016 Christian Bach, Robert Spann, Hilde Larsson, Ines Larsson, Mads Orla Albaek, Krist V. Gernaey, Ulrich Krühne
Computational Fluid Dynamics - en genvej til procesindsigt
published pages: 14-17, ISSN: , DOI:
Dansk Kemi 10, 2016 2020-01-21
2017 Emmanuel Anane, Diana C. López C, Peter Neubauer, M. Nicolas Cruz Bournazou
Modelling overflow metabolism in Escherichia coli by acetate cycling
published pages: , ISSN: 1369-703X, DOI: 10.1016/j.bej.2017.05.013
Biochemical Engineering Journal 2020-01-21
2016 Arathi Kizhedath, Simon Wilkinson, Jarka Glassey
Applicability of predictive toxicology methods for monoclonal antibody therapeutics: status Quo and scope
published pages: , ISSN: 0340-5761, DOI: 10.1007/s00204-016-1876-7
Archives of Toxicology 2020-01-21
2016 Patricia Roch, Carl-Fredrik Mandenius
On-line monitoring of downstream bioprocesses
published pages: 112-120, ISSN: 2211-3398, DOI: 10.1016/j.coche.2016.09.007
Current Opinion in Chemical Engineering 14 2020-01-21

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