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 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.

Identifying the elements of entrepreneurial opportunity constructs

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.