Integrated Process Model Applications Linking Bioprocess Development to Quality by Design Milestones

Maximizing the value of each available data point in bioprocess development is essential in order to reduce the time-to-market, lower the number of expensive wet-lab experiments, and maximize process understanding. Advanced in silico methods are increasingly being investigated to accomplish these go...

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Autores principales:	Christopher Taylor, Lukas Marschall, Marco Kunzelmann, Michael Richter, Frederik Rudolph, Judith Vajda, Beate Presser, Thomas Zahel, Joey Studts, Christoph Herwig
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	digital twin QbD integrated process model statistical modelling bioprocess control strategy Technology T Biology (General) QH301-705.5
Acceso en línea:	https://doaj.org/article/53b6d903e149417d90f0b2951937ec32
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spelling	oai:doaj.org-article:53b6d903e149417d90f0b2951937ec322021-11-25T16:46:24ZIntegrated Process Model Applications Linking Bioprocess Development to Quality by Design Milestones10.3390/bioengineering81101562306-5354https://doaj.org/article/53b6d903e149417d90f0b2951937ec322021-10-01T00:00:00Zhttps://www.mdpi.com/2306-5354/8/11/156https://doaj.org/toc/2306-5354Maximizing the value of each available data point in bioprocess development is essential in order to reduce the time-to-market, lower the number of expensive wet-lab experiments, and maximize process understanding. Advanced in silico methods are increasingly being investigated to accomplish these goals. Within this contribution, we propose a novel integrated process model procedure to maximize the use of development data to optimize the Stage 1 process validation work flow. We generate an integrated process model based on available data and apply two innovative Monte Carlo simulation-based parameter sensitivity analysis linearization techniques to automate two quality by design activities: determining risk assessment severity rankings and establishing preliminary control strategies for critical process parameters. These procedures are assessed in a case study for proof of concept on a candidate monoclonal antibody bioprocess after process development, but prior to process characterization. The evaluation was successful in returning results that were used to support Stage I process validation milestones and demonstrated the potential to reduce the investigated parameters by up to 24% in process characterization, while simultaneously setting up a strategy for iterative updates of risk assessments and process controls throughout the process life-cycle to ensure a robust and efficient drug supply.Christopher TaylorLukas MarschallMarco KunzelmannMichael RichterFrederik RudolphJudith VajdaBeate PresserThomas ZahelJoey StudtsChristoph HerwigMDPI AGarticledigital twinQbDintegrated process modelstatistical modellingbioprocesscontrol strategyTechnologyTBiology (General)QH301-705.5ENBioengineering, Vol 8, Iss 156, p 156 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	digital twin QbD integrated process model statistical modelling bioprocess control strategy Technology T Biology (General) QH301-705.5
spellingShingle	digital twin QbD integrated process model statistical modelling bioprocess control strategy Technology T Biology (General) QH301-705.5 Christopher Taylor Lukas Marschall Marco Kunzelmann Michael Richter Frederik Rudolph Judith Vajda Beate Presser Thomas Zahel Joey Studts Christoph Herwig Integrated Process Model Applications Linking Bioprocess Development to Quality by Design Milestones
description	Maximizing the value of each available data point in bioprocess development is essential in order to reduce the time-to-market, lower the number of expensive wet-lab experiments, and maximize process understanding. Advanced in silico methods are increasingly being investigated to accomplish these goals. Within this contribution, we propose a novel integrated process model procedure to maximize the use of development data to optimize the Stage 1 process validation work flow. We generate an integrated process model based on available data and apply two innovative Monte Carlo simulation-based parameter sensitivity analysis linearization techniques to automate two quality by design activities: determining risk assessment severity rankings and establishing preliminary control strategies for critical process parameters. These procedures are assessed in a case study for proof of concept on a candidate monoclonal antibody bioprocess after process development, but prior to process characterization. The evaluation was successful in returning results that were used to support Stage I process validation milestones and demonstrated the potential to reduce the investigated parameters by up to 24% in process characterization, while simultaneously setting up a strategy for iterative updates of risk assessments and process controls throughout the process life-cycle to ensure a robust and efficient drug supply.
format	article
author	Christopher Taylor Lukas Marschall Marco Kunzelmann Michael Richter Frederik Rudolph Judith Vajda Beate Presser Thomas Zahel Joey Studts Christoph Herwig
author_facet	Christopher Taylor Lukas Marschall Marco Kunzelmann Michael Richter Frederik Rudolph Judith Vajda Beate Presser Thomas Zahel Joey Studts Christoph Herwig
author_sort	Christopher Taylor
title	Integrated Process Model Applications Linking Bioprocess Development to Quality by Design Milestones
title_short	Integrated Process Model Applications Linking Bioprocess Development to Quality by Design Milestones
title_full	Integrated Process Model Applications Linking Bioprocess Development to Quality by Design Milestones
title_fullStr	Integrated Process Model Applications Linking Bioprocess Development to Quality by Design Milestones
title_full_unstemmed	Integrated Process Model Applications Linking Bioprocess Development to Quality by Design Milestones
title_sort	integrated process model applications linking bioprocess development to quality by design milestones
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/53b6d903e149417d90f0b2951937ec32
work_keys_str_mv	AT christophertaylor integratedprocessmodelapplicationslinkingbioprocessdevelopmenttoqualitybydesignmilestones AT lukasmarschall integratedprocessmodelapplicationslinkingbioprocessdevelopmenttoqualitybydesignmilestones AT marcokunzelmann integratedprocessmodelapplicationslinkingbioprocessdevelopmenttoqualitybydesignmilestones AT michaelrichter integratedprocessmodelapplicationslinkingbioprocessdevelopmenttoqualitybydesignmilestones AT frederikrudolph integratedprocessmodelapplicationslinkingbioprocessdevelopmenttoqualitybydesignmilestones AT judithvajda integratedprocessmodelapplicationslinkingbioprocessdevelopmenttoqualitybydesignmilestones AT beatepresser integratedprocessmodelapplicationslinkingbioprocessdevelopmenttoqualitybydesignmilestones AT thomaszahel integratedprocessmodelapplicationslinkingbioprocessdevelopmenttoqualitybydesignmilestones AT joeystudts integratedprocessmodelapplicationslinkingbioprocessdevelopmenttoqualitybydesignmilestones AT christophherwig integratedprocessmodelapplicationslinkingbioprocessdevelopmenttoqualitybydesignmilestones
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Integrated Process Model Applications Linking Bioprocess Development to Quality by Design Milestones

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