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

2021 ◽  
Vol 8 (11) ◽  
pp. 156
Author(s):  
Christopher Taylor ◽  
Lukas Marschall ◽  
Marco Kunzelmann ◽  
Michael Richter ◽  
Frederik Rudolph ◽  
...  
Keyword(s):  
Process Model ◽  
Quality By Design ◽  
Process Development ◽  
Control Strategies ◽  
Integrated Process ◽  
Bioprocess Development ◽  
Process Validation ◽  
Process Characterization ◽  
Design Activities ◽  
Integrated Process Model

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.

scholarly journals An integrated process model of stereotype threat effects on performance.

2008 ◽  
Vol 115 (2) ◽  
pp. 336-356 ◽  
Author(s):  
Toni Schmader ◽  
Michael Johns ◽  
Chad Forbes
Keyword(s):  
Stereotype Threat ◽  
Process Model ◽  
Integrated Process ◽  
Integrated Process Model

An integrated-process model of service quality, institutional brand and behavioural intentions

2014 ◽  
Vol 24 (5) ◽  
pp. 487-521 ◽  
Author(s):  
Parves Sultan ◽  
Ho Yin Wong
Keyword(s):  
Service Quality ◽  
Process Model ◽  
Global Market ◽  
Past Experience ◽  
Integrated Process ◽  
Content Type ◽  
Behavioural Intentions ◽  
Index Model ◽  
Quality Literature ◽  
Integrated Process Model

Purpose – The purpose of this paper is to develop and test an integrated-process model/an index model by incorporating the antecedents and consequences of service quality in a higher education context. Design/methodology/approach – This research employed both qualitative and quantitative research methods. The data from three focus groups, conducted at an Australian University, generated key themes and their interrelationships. The theoretical model was then tested using the structural equation modelling (SEM) technique on a sample of 528 University students. Findings – The findings show that information (or marketing communications) and past experience are the antecedents of perceived service quality (PSQ). PSQ is a second order construct and has three dimensions: academic, administrative and facilities. The consequences of PSQ include trust, satisfaction, university-brand (UniBrand) performance and behavioural intentions. Overall, the results suggest a good validity of the model, and the nine path coefficients are found statistically significant. Originality/value – The model explains how service quality is formed, and how PSQ affects UniBrand and positive behavioural intentions overtime. This paper develops and validates three new constructs including information, past experience and UniBrand performance. In addition, it improves and validates other constructs including service quality, satisfaction, trust and behavioural intention. The paper also advances service quality literature and validates five hypothesised relationships between constructs that are relatively new in the service quality literature. Finally, this study validates a comprehensive three-tiered “integrated-process” model/an index model that includes antecedents, dimensions and consequences of service quality taking a University as a case. Universities aiming for a sustainable presence in a competitive global market and intending to enhance brand performance and attract and retain students are encouraged to consider this model and its implications.

Identifying the elements of entrepreneurial opportunity constructs

2016 ◽  
Vol 17 (4) ◽  
pp. 240-255 ◽  
Author(s):  
David J. Hansen ◽  
Javier Monllor ◽  
Rodney C. Shrader
Keyword(s):  
Process Model ◽  
Model Comparison ◽  
Future Research ◽  
Integrated Process ◽  
Entrepreneurial Opportunity ◽  
Important Phenomenon ◽  
Integrated Process Model

There is plenty of debate in the entrepreneurship literature regarding entrepreneurial opportunity. There also has been a lack of construct clarity. These two issues have combined to stifle progress in understanding this important phenomenon. We believe that across these debates there are many underlying commonalities and potential for more clear constructs. In this article, we review how scholars have defined and operationalized entrepreneurial opportunity and opportunity-related processes in order to better understand what they really mean when they say ‘opportunity’. We found a total of 102 definitions and 51 operationalizations from 105 articles published in leading entrepreneurship and management journals. A total of 81 elements were identified across the definitions and operationalizations and compiled into an integrated process model. The model incorporates what seemed to be disparate views into a single unifying model. Comparison between conceptual definitions and operationalizations reveals many elements that are missing either conceptual or empirical attention. The model will help scholars more easily identify and build upon prior research. To that effect, numerous suggestions for future research are discussed and are summarized in a table.

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