Rapid Bioprocess Development

Deliverables

Immune/media sensors tested in industrial conditions
PhD theses complete

PhD theses complete where appropriate

Overall framework for rapid screening, process development and monitoring
Predictive models for the behaviour of two bioactive molecules in response to processing conditions
Report on appropriate modelling methodologies for soft sensor development for model process of partners
General framework for data representation with small batch numbers, across process scales
Methodology to investigate population heterogeneity formulated
Two complete case studies (i) a manufacturing system for recombinant biopharmaceutical, and (ii) a manufacturing system for a drug compound
Methodology to investigate oscillation effects on product quality
Report on most appropriate modelling approaches for the general bioprocess monitoring framework
Report on the most appropriate modelling methods for prediction of processing routes
Two soft sensors adapted to impurity control of chromatography

Two soft sensors adapted to impurity control of chromatography one at month 25 the other at 42

PAT system design under uncertainty: practical validation on a lab-scale recombinant yeast fermentation
Rapid bioprocess development strategy for diverse biomolecule structures
Dissemination plan formally approved
Soft sensor system developed and tested in industrial conditions

Population heterogeneity methodology tested on model system
BioRapid mid-term and final conferences

BioRapid mid-term and final conferences at months 24 and 48

DoE and optimal design tested on a model system
Project website and webinar/e-seminar software setup

Set up of the website for dissemination and for project communications

Framework for PAT system design under uncertainty
Oscillation effect/product quality methodology tested on model system
Modelling framework for rapid screening of toxicity/immunogenicity of bioactives

DoE and optimal design validated on industrial case study

Publications

Applicability of Traditional In Vitro Toxicity Tests for Assessing Adverse Effects of Monoclonal Antibodies: A Case Study of Rituximab and Trastuzumab

Author(s): Arathi Kizhedath, Simon Wilkinson, Jarka Glassey
Published in: Antibodies, Issue 7/3, 2018, Page(s) 30, ISSN 2073-4468
Publisher: MDPI AG
DOI: 10.3390/antib7030030

Exploiting mAb structure characteristics for a directed QbD implementation in early process development

Author(s): Micael Karlberg, Moritz von Stosch, Jarka Glassey
Published in: Critical Reviews in Biotechnology, Issue 38/6, 2017, Page(s) 957-970, ISSN 0738-8551
Publisher: Taylor & Francis
DOI: 10.1080/07388551.2017.1421899

Machine learning in biopharmaceutical manufacturing

Author(s): Guerra AC, Glassey J.
Published in: European Pharmaceutical Review, Issue 23(4), 2018, Page(s) 62-65, ISSN 1360-8606
Publisher: Russell Publishing Ltd

The importance of critical quality attributes in Quality by Design for rapid bioprocess development strategies

Author(s): Kizhedath, A., Glassey, J:
Published in: European Pharmaceutical Review, Issue 22(6), 2017, Page(s) 48-50, ISSN 1360-8606
Publisher: Russell Publishing Ltd

Assessment of hepatotoxicity and dermal toxicity of butyl paraben and methyl paraben using HepG2 and HDFn in vitro models

Author(s): Arathi Kizhedath, Simon Wilkinson, Jarka Glassey
Published in: Toxicology in Vitro, 2018, ISSN 0887-2333
Publisher: Elsevier BV
DOI: 10.1016/j.tiv.2018.12.007

Modelling concentration gradients in fed-batch cultivations of E. coli - towards the flexible design of scale-down experiments

Author(s): Emmanuel Anane, Annina Sawatzki, Peter Neubauer, Mariano Nicolas Cruz-Bournazou
Published in: Journal of Chemical Technology & Biotechnology, 2018, ISSN 0268-2575
Publisher: John Wiley & Sons Inc.
DOI: 10.1002/jctb.5798

Electrooptical Determination of Polarizability for On-Line Viability and Vitality Quantification of Lactobacillus plantarum Cultures

Author(s): Klaus Pellicer-Alborch, Alexander Angersbach, Peter Neubauer, Stefan Junne
Published in: Frontiers in Bioengineering and Biotechnology, Issue 6, 2018, ISSN 2296-4185
Publisher: Frontiers
DOI: 10.3389/fbioe.2018.00188

Applicability of predictive toxicology methods for monoclonal antibody therapeutics: status Quo and scope

Author(s): Arathi Kizhedath, Simon Wilkinson, Jarka Glassey
Published in: Archives of Toxicology, 2016, ISSN 0340-5761
Publisher: Springer Verlag
DOI: 10.1007/s00204-016-1876-7

On-line monitoring of downstream bioprocesses

Author(s): Patricia Roch, Carl-Fredrik Mandenius
Published in: Current Opinion in Chemical Engineering, Issue 14, 2016, Page(s) 112-120, ISSN 2211-3398
Publisher: Elsevier BV
DOI: 10.1016/j.coche.2016.09.007

Comparison of time‐gated surface‐enhanced raman spectroscopy (TG‐SERS) and classical SERS based monitoring of Escherichia coli cultivation samples

Author(s): Martin Kögler, Andrea Paul, Emmanuel Anane, Mario Birkholz, Alex Bunker, Tapani Viitala, Michael Maiwald, Stefan Junne, Peter Neubauer
Published in: Biotechnology Progress, Issue 34/6, 2018, Page(s) 1533-1542, ISSN 8756-7938
Publisher: American Chemical Society
DOI: 10.1002/btpr.2665

On-line soft sensing in upstream bioprocessing

Author(s): Judit Randek, Carl-Fredrik Mandenius
Published in: Critical Reviews in Biotechnology, Issue 38/1, 2017, Page(s) 106-121, ISSN 0738-8551
Publisher: Taylor & Francis
DOI: 10.1080/07388551.2017.1312271

A probabilistic model-based soft sensor to monitor lactic acid bacteria fermentations

Author(s): Robert Spann, Christophe Roca, David Kold, Anna Eliasson Lantz, Krist V. Gernaey, Gürkan Sin
Published in: Biochemical Engineering Journal, Issue 135, 2018, Page(s) 49-60, ISSN 1369-703X
Publisher: Elsevier BV
DOI: 10.1016/j.bej.2018.03.016

CFD predicted pH gradients in lactic acid bacteria cultivations

Author(s): 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
Published in: Biotechnology and Bioengineering, 2018, ISSN 0006-3592
Publisher: Wiley - V C H Verlag GmbbH & Co.
DOI: 10.1002/bit.26868

Cross interaction chromatography based QSAR model for early stage screening to facilitate enhanced developability of monoclonal antibody therapeutics

Author(s): Kizhedath, A., Karlberg, M., Glassey, J
Published in: Biotechnology Journal, 2019, ISSN 1860-6768
Publisher: Wiley - VCH Verlag GmbH & CO. KGaA
DOI: 10.1002/biot.201800696

Modelling overflow metabolism in Escherichia coli by acetate cycling

Author(s): Emmanuel Anane, Diana C. López C, Peter Neubauer, M. Nicolas Cruz Bournazou
Published in: Biochemical Engineering Journal, 2017, ISSN 1369-703X
Publisher: Elsevier BV
DOI: 10.1016/j.bej.2017.05.013

CFD in single-use bioreactors support scale-up in mammalian cell culture

Author(s): Konakovsky, V, Andersen, M.G, Tajsoleiman, T, McCreath, G, Krühne, U, Glassey, J.
Published in: ESBES Conference proceedings, 2018
Publisher: ESBES

Exploiting mAb structure characteristics for a directed QbD implementation in process development

Author(s): Karlberg, M, Glassey, J:
Published in: ESBES Conference proceedings, 2018
Publisher: ESBES

Hybrid modelling approaches for early stage screening of monoclonal antibodies based on safety for rapid mAb developability

Author(s): Kizhedath, A, Wilkinson, S, Glassey, J
Published in: ESBES Conference proceedings, 2018
Publisher: ESBES

Soft-sensor platform for biopharmaceutical development and manufacturing

Author(s): Guerra, A, Dalton, J, Glassey, J
Published in: ESBES Conference proceedings, 2018
Publisher: ESBES

Bioprocess development: moving through the scales with more confidence

Author(s): Glassey J
Published in: Bioprocessing European Summit, 2018
Publisher: Bioprocessing European Summit

Using machine learning tools in bioprocess scale up when the number of batches is small

Author(s): Konakovsky, V, McCreath, G, Glassey, J
Published in: AICHE, 2018
Publisher: AICHE

Early adverse-effect prediction using hybrid-based modelling

Author(s): Kizhedath, A, Wilkinson, S, Glassey, J.
Published in: WCCE, 2017
Publisher: WCCE

Exploiting mAb structure characteristics for rapid screening and a directed QbD implementation in process development

Author(s): Karlberg, M, Kizhedath, A., von Stosch, M, Wilkinson, S, Glassey J
Published in: ACS Biot, 2017
Publisher: ACS

Exploiting mAb structure characteristics for a directed QbD implementation in process development

Author(s): Karlberg, M, von Stosch, M, Glassey, J
Published in: WCCE, 2017
Publisher: WCCE

An industrial perspective on using ambr as scale down models in mammalian cell culture

Author(s): Konakovsky, V, McCreath, G, Glassey, J
Published in: ESACT, 2017
Publisher: ESACT

Which scale down model heuristics should we use in ambr bioreactors?

Author(s): Konakovsky, V, McCreath, G, Glassey, J
Published in: Bioprocess UK XIII, 2016
Publisher: Biorpocess UK

Early toxicity prediction using hybrid-based modelling

Author(s): Kizhedath, A, Wilkinson S, Glassey J
Published in: Biorpocess UK XIII, 2016
Publisher: Bioprocess

Supervision Modelling Framework for Bioprocesses

Author(s): Guerra, A, von Stosch, M, Glassey, J
Published in: Bioprocess XIII, 2016
Publisher: Bioprocess UK

Detecting the Aggregation of Antibodies by Analytical Ultracentrifugation

Author(s): Kizhedath A, Solovyova A, Glassey J
Published in: Bioprocess XIII, 2016
Publisher: Bioprocess

Early Bioprocess development using PAT approaches

Author(s): Karlberg, M, von Stosch, M, McCreath, G, Glassey, J
Published in: ESBES, 2016
Publisher: ESBES

M3C in Mammalian Cell Cultures: Data Pre-processing Methods

Author(s): Guerra, A, von Stosch, M, Glassey, J
Published in: ESBES, 2016
Publisher: ESBES

Early toxicity prediction using hybrid-based modelling

Author(s): Kizhedath, A, Wilkinson, S, Glassey, J
Published in: ESBES, 2016
Publisher: ESBES

Early toxicity prediction using hybrid-based modelling

Author(s): Kizhedath, A, Wilkinson, S, Glassey, J
Published in: EuroQSAR, 2016
Publisher: EuroQSAR

Accelerated bioprocess characterization by data enrichment in scale-down models

Author(s): Konakovsky, V, McCreath, G and Glassey J:
Published in: Cell Culture Engineering, 2016
Publisher: Cell Culture Engineering

Scale down model characterization using Ambr 250 and SUB

Author(s): Konakovsky, V, Sully, S, Slingsby, F, McCreath, G, Glassey, J
Published in: BPI Europe, 2016
Publisher: BPI Europe

Data augmentation of high-throughput bioprocesses by rapid streamlining algorithms

Author(s): Konakovsky, V, McCreath, G and Glassey J
Published in: Biorpocess XII, 2015
Publisher: Bioprocess

Assessment of hepatotoxicity and dermal toxicity of butyl paraben and methyl paraben using HepG2 and HDFn in vitro models

Author(s): Kizhedath, A, Wilkinson, S, Glassey, J
Published in: British Toxicology Society, 2018
Publisher: British Toxicology Society

Early stage adverse effect prediction for rapid screening and developability of monoclonal antibody therapeutics using a hybrid modelling framework

Author(s): Kizhedath, A, Wilkinson, S, Glassey, J
Published in: British Toxicology Society, 2018
Publisher: British Toxicology Society

An Efficient Experimental Design Strategy for Modelling and Characterization of Processes

Author(s): Tannaz Tajsoleiman, Daria Semenova, Ana C. Fernandes, Jakob Kjøbsted Huusom, Krist V. Gernaey and Ulrich Krühne
Published in: Proceedings of the 27th European Symposium on Computer Aided Process Engineering – ESCAPE 27, 2017, Page(s) 1-6, ISBN 9780-444639653
Publisher: Elsevier

A Consistent Methodology Based Parameter Estimation for a Lactic Acid Bacteria Fermentation Model

Author(s): Robert Spann, Christophe Roca, David Kold, Anna Eliasson Lantz, Krist V.Gernaey and Gürkan Sin
Published in: Proceedings of the 27th European Symposium on Computer Aided Process Engineering – ESCAPE 27, 2017, ISBN 9780-444639653
Publisher: Elsevier

Computational Fluid Dynamics - en genvej til procesindsigt

Author(s): Christian Bach, Robert Spann, Hilde Larsson, Ines Larsson, Mads Orla Albaek, Krist V. Gernaey, Ulrich Krühne
Published in: Dansk Kemi, Issue 10, 2016, 2016, Page(s) 14-17
Publisher: TechMedia

Model-based process development for a continuous lactic acid bacteria fermentation

Author(s): Robert Spann, Anna Eliasson Lantz, Christophe Roca, Krist V. Gernaey, Gürkan Sin
Published in: 28th European Symposium on Computer Aided Process Engineering, Issue 43, 2018, Page(s) 1601-1606, ISBN 9780-444642356
Publisher: Elsevier
DOI: 10.1016/b978-0-444-64235-6.50279-5

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Deliverables

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