Rapid Bioprocess Development

Resultado final

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

Publicaciones

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

Autores: Arathi Kizhedath, Simon Wilkinson, Jarka Glassey
Publicado en: Antibodies, Edición 7/3, 2018, Página(s) 30, ISSN 2073-4468
Editor: MDPI AG
DOI: 10.3390/antib7030030

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

Autores: Micael Karlberg, Moritz von Stosch, Jarka Glassey
Publicado en: Critical Reviews in Biotechnology, Edición 38/6, 2017, Página(s) 957-970, ISSN 0738-8551
Editor: Taylor & Francis
DOI: 10.1080/07388551.2017.1421899

Machine learning in biopharmaceutical manufacturing

Autores: Guerra AC, Glassey J.
Publicado en: European Pharmaceutical Review, Edición 23(4), 2018, Página(s) 62-65, ISSN 1360-8606
Editor: Russell Publishing Ltd

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

Autores: Kizhedath, A., Glassey, J:
Publicado en: European Pharmaceutical Review, Edición 22(6), 2017, Página(s) 48-50, ISSN 1360-8606
Editor: Russell Publishing Ltd

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

Autores: Arathi Kizhedath, Simon Wilkinson, Jarka Glassey
Publicado en: Toxicology in Vitro, 2018, ISSN 0887-2333
Editor: 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

Autores: Emmanuel Anane, Annina Sawatzki, Peter Neubauer, Mariano Nicolas Cruz-Bournazou
Publicado en: Journal of Chemical Technology & Biotechnology, 2018, ISSN 0268-2575
Editor: John Wiley & Sons Inc.
DOI: 10.1002/jctb.5798

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

Autores: Klaus Pellicer-Alborch, Alexander Angersbach, Peter Neubauer, Stefan Junne
Publicado en: Frontiers in Bioengineering and Biotechnology, Edición 6, 2018, ISSN 2296-4185
Editor: Frontiers
DOI: 10.3389/fbioe.2018.00188

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

Autores: Arathi Kizhedath, Simon Wilkinson, Jarka Glassey
Publicado en: Archives of Toxicology, 2016, ISSN 0340-5761
Editor: Springer Verlag
DOI: 10.1007/s00204-016-1876-7

On-line monitoring of downstream bioprocesses

Autores: Patricia Roch, Carl-Fredrik Mandenius
Publicado en: Current Opinion in Chemical Engineering, Edición 14, 2016, Página(s) 112-120, ISSN 2211-3398
Editor: 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

Autores: Martin Kögler, Andrea Paul, Emmanuel Anane, Mario Birkholz, Alex Bunker, Tapani Viitala, Michael Maiwald, Stefan Junne, Peter Neubauer
Publicado en: Biotechnology Progress, Edición 34/6, 2018, Página(s) 1533-1542, ISSN 8756-7938
Editor: American Chemical Society
DOI: 10.1002/btpr.2665

On-line soft sensing in upstream bioprocessing

Autores: Judit Randek, Carl-Fredrik Mandenius
Publicado en: Critical Reviews in Biotechnology, Edición 38/1, 2017, Página(s) 106-121, ISSN 0738-8551
Editor: Taylor & Francis
DOI: 10.1080/07388551.2017.1312271

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

Autores: Robert Spann, Christophe Roca, David Kold, Anna Eliasson Lantz, Krist V. Gernaey, Gürkan Sin
Publicado en: Biochemical Engineering Journal, Edición 135, 2018, Página(s) 49-60, ISSN 1369-703X
Editor: Elsevier BV
DOI: 10.1016/j.bej.2018.03.016

CFD predicted pH gradients in lactic acid bacteria cultivations

Autores: 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
Publicado en: Biotechnology and Bioengineering, 2018, ISSN 0006-3592
Editor: 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

Autores: Kizhedath, A., Karlberg, M., Glassey, J
Publicado en: Biotechnology Journal, 2019, ISSN 1860-6768
Editor: Wiley - VCH Verlag GmbH & CO. KGaA
DOI: 10.1002/biot.201800696

Modelling overflow metabolism in Escherichia coli by acetate cycling

Autores: Emmanuel Anane, Diana C. López C, Peter Neubauer, M. Nicolas Cruz Bournazou
Publicado en: Biochemical Engineering Journal, 2017, ISSN 1369-703X
Editor: Elsevier BV
DOI: 10.1016/j.bej.2017.05.013

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

Autores: Konakovsky, V, Andersen, M.G, Tajsoleiman, T, McCreath, G, Krühne, U, Glassey, J.
Publicado en: ESBES Conference proceedings, 2018
Editor: ESBES

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

Autores: Karlberg, M, Glassey, J:
Publicado en: ESBES Conference proceedings, 2018
Editor: ESBES

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

Autores: Kizhedath, A, Wilkinson, S, Glassey, J
Publicado en: ESBES Conference proceedings, 2018
Editor: ESBES

Soft-sensor platform for biopharmaceutical development and manufacturing

Autores: Guerra, A, Dalton, J, Glassey, J
Publicado en: ESBES Conference proceedings, 2018
Editor: ESBES

Bioprocess development: moving through the scales with more confidence

Autores: Glassey J
Publicado en: Bioprocessing European Summit, 2018
Editor: Bioprocessing European Summit

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

Autores: Konakovsky, V, McCreath, G, Glassey, J
Publicado en: AICHE, 2018
Editor: AICHE

Early adverse-effect prediction using hybrid-based modelling

Autores: Kizhedath, A, Wilkinson, S, Glassey, J.
Publicado en: WCCE, 2017
Editor: WCCE

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

Autores: Karlberg, M, Kizhedath, A., von Stosch, M, Wilkinson, S, Glassey J
Publicado en: ACS Biot, 2017
Editor: ACS

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

Autores: Karlberg, M, von Stosch, M, Glassey, J
Publicado en: WCCE, 2017
Editor: WCCE

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

Autores: Konakovsky, V, McCreath, G, Glassey, J
Publicado en: ESACT, 2017
Editor: ESACT

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

Autores: Konakovsky, V, McCreath, G, Glassey, J
Publicado en: Bioprocess UK XIII, 2016
Editor: Biorpocess UK

Early toxicity prediction using hybrid-based modelling

Autores: Kizhedath, A, Wilkinson S, Glassey J
Publicado en: Biorpocess UK XIII, 2016
Editor: Bioprocess

Supervision Modelling Framework for Bioprocesses

Autores: Guerra, A, von Stosch, M, Glassey, J
Publicado en: Bioprocess XIII, 2016
Editor: Bioprocess UK

Detecting the Aggregation of Antibodies by Analytical Ultracentrifugation

Autores: Kizhedath A, Solovyova A, Glassey J
Publicado en: Bioprocess XIII, 2016
Editor: Bioprocess

Early Bioprocess development using PAT approaches

Autores: Karlberg, M, von Stosch, M, McCreath, G, Glassey, J
Publicado en: ESBES, 2016
Editor: ESBES

M3C in Mammalian Cell Cultures: Data Pre-processing Methods

Autores: Guerra, A, von Stosch, M, Glassey, J
Publicado en: ESBES, 2016
Editor: ESBES

Early toxicity prediction using hybrid-based modelling

Autores: Kizhedath, A, Wilkinson, S, Glassey, J
Publicado en: ESBES, 2016
Editor: ESBES

Early toxicity prediction using hybrid-based modelling

Autores: Kizhedath, A, Wilkinson, S, Glassey, J
Publicado en: EuroQSAR, 2016
Editor: EuroQSAR

Accelerated bioprocess characterization by data enrichment in scale-down models

Autores: Konakovsky, V, McCreath, G and Glassey J:
Publicado en: Cell Culture Engineering, 2016
Editor: Cell Culture Engineering

Scale down model characterization using Ambr 250 and SUB

Autores: Konakovsky, V, Sully, S, Slingsby, F, McCreath, G, Glassey, J
Publicado en: BPI Europe, 2016
Editor: BPI Europe

Data augmentation of high-throughput bioprocesses by rapid streamlining algorithms

Autores: Konakovsky, V, McCreath, G and Glassey J
Publicado en: Biorpocess XII, 2015
Editor: Bioprocess

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

Autores: Kizhedath, A, Wilkinson, S, Glassey, J
Publicado en: British Toxicology Society, 2018
Editor: British Toxicology Society

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

Autores: Kizhedath, A, Wilkinson, S, Glassey, J
Publicado en: British Toxicology Society, 2018
Editor: British Toxicology Society

An Efficient Experimental Design Strategy for Modelling and Characterization of Processes

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

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

Autores: Robert Spann, Christophe Roca, David Kold, Anna Eliasson Lantz, Krist V.Gernaey and Gürkan Sin
Publicado en: Proceedings of the 27th European Symposium on Computer Aided Process Engineering – ESCAPE 27, 2017, ISBN 9780-444639653
Editor: Elsevier

Computational Fluid Dynamics - en genvej til procesindsigt

Autores: Christian Bach, Robert Spann, Hilde Larsson, Ines Larsson, Mads Orla Albaek, Krist V. Gernaey, Ulrich Krühne
Publicado en: Dansk Kemi, Edición 10, 2016, 2016, Página(s) 14-17
Editor: TechMedia

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

Autores: Robert Spann, Anna Eliasson Lantz, Christophe Roca, Krist V. Gernaey, Gürkan Sin
Publicado en: 28th European Symposium on Computer Aided Process Engineering, Edición 43, 2018, Página(s) 1601-1606, ISBN 9780-444642356
Editor: Elsevier
DOI: 10.1016/b978-0-444-64235-6.50279-5

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