The Experts below are selected from a list of 4560 Experts worldwide ranked by ideXlab platform
Paul Rice - One of the best experts on this subject based on the ideXlab platform.
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hybrid modeling for quality by design and pat benefits and challenges of applications in Biopharmaceutical Industry
Biotechnology Journal, 2014Co-Authors: Moritz Von Stosch, Steven Davy, Kjell Francois, Vytautas Galvanauskas, Jan Martijn Hamelink, Andreas Luebbert, Martin Mayer, Rui Oliveira, Ronan Okennedy, Paul RiceAbstract:This report highlights the drivers, challenges, and enablers of the hybrid modeling applications in Biopharmaceutical Industry. It is a summary of an expert panel discussion of European academics and industrialists with relevant scientific and engineering backgrounds. Hybrid modeling is viewed in its broader sense, namely as the integration of different knowledge sources in form of parametric and nonparametric models into a hybrid semi-parametric model, for instance the integration of fundamental and data-driven models. A brief description of the current state-of-the-art and industrial uptake of the methodology is provided. The report concludes with a number of recommendations to facilitate further developments and a wider industrial application of this modeling approach. These recommendations are limited to further exploiting the benefits of this methodology within process analytical technology (PAT) applications in Biopharmaceutical Industry.
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Hybrid modeling for quality by design and PAT‐benefits and challenges of applications in Biopharmaceutical Industry
Biotechnology journal, 2014Co-Authors: Moritz Von Stosch, Steven Davy, Kjell Francois, Vytautas Galvanauskas, Jan Martijn Hamelink, Andreas Luebbert, Martin Mayer, Rui Oliveira, Ronan O'kennedy, Paul RiceAbstract:This report highlights the drivers, challenges, and enablers of the hybrid modeling applications in Biopharmaceutical Industry. It is a summary of an expert panel discussion of European academics and industrialists with relevant scientific and engineering backgrounds. Hybrid modeling is viewed in its broader sense, namely as the integration of different knowledge sources in form of parametric and nonparametric models into a hybrid semi-parametric model, for instance the integration of fundamental and data-driven models. A brief description of the current state-of-the-art and industrial uptake of the methodology is provided. The report concludes with a number of recommendations to facilitate further developments and a wider industrial application of this modeling approach. These recommendations are limited to further exploiting the benefits of this methodology within process analytical technology (PAT) applications in Biopharmaceutical Industry.
Shishir Gadam - One of the best experts on this subject based on the ideXlab platform.
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Process Scale Bioseparations for the Biopharmaceutical Industry - Process scale bioseparations for the Biopharmaceutical Industry
2006Co-Authors: Abhinav A. Shukla, Mark R. Etzel, Shishir GadamAbstract:Process scale bioseparations for the Biopharmaceutical Industry , Process scale bioseparations for the Biopharmaceutical Industry , کتابخانه مرکزی دانشگاه علوم پزشکی تهران
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process scale bioseparations for the Biopharmaceutical Industry
2006Co-Authors: Abhinav A. Shukla, Mark R. Etzel, Shishir GadamAbstract:Process scale bioseparations for the Biopharmaceutical Industry , Process scale bioseparations for the Biopharmaceutical Industry , کتابخانه مرکزی دانشگاه علوم پزشکی تهران
Zeynep Erden - One of the best experts on this subject based on the ideXlab platform.
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The publishing and patenting strategies of successful university spinoffs in the Biopharmaceutical Industry.
Drug discovery today, 2016Co-Authors: Zeynep ErdenAbstract:Firms in the Biopharmaceutical Industry send signals to investors about the value of their knowledge by disclosing it in the form of patents and publications. In this way, they can gain reputation even before having products on the market. This paper compares the patenting and publishing activities of university spinoffs with other Biopharmaceutical firms. The findings suggest that successful university spinoffs and successful other firms (not university spinoffs) tend to follow different knowledge disclosure strategies. Whereas successful university spinoffs tend to emphasize the scientific value of their knowledge and gain reputation through their high-quality publications, other successful firms tend to emphasize the commercial value of their knowledge and gain reputation through high-quality patents.
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Clusters in the Biopharmaceutical Industry: toward a new method of analysis.
Drug discovery today, 2011Co-Authors: Zeynep Erden, Georg Von KroghAbstract:Clusters are groups of co-located and interconnected firms and institutions linked by commonalities in their strategies and complementarities in their activities and resources. There are several reasons for the geographical clustering of firms in the Biopharmaceutical Industry. This review unpacks some advantages and disadvantages of cluster participation, and proposes a new method to enable managers and researchers to identify clusters in the Biopharmaceutical Industry.
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Strategic groups in the Biopharmaceutical Industry: implications for performance.
Drug discovery today, 2009Co-Authors: Zeynep Erden, Georg Von Krogh, Cecilia Nytorp, Marcus HultbergAbstract:The Biopharmaceutical Industry is characterized by intense competition, high uncertainty, and strong dependence on scientific knowledge. We show that in order to succeed in this Industry, firms need to be positioned along three strategic dimensions: the level of inter-firm R&D partnering, the level of diversification, and the size of the firm. Prior research has revealed that a firm's membership in so-called 'strategic groups' impacts strongly on its performance. This study analyzes strategic groups in the Biopharmaceutical Industry along the strategic dimensions listed. The performance of the groups differs significantly. The best performing groups are the ones that consist of large firms with a high level of in-house diversification across therapeutic areas and the medium-sized firms that pursue partnership with other companies.
Nigel Allison - One of the best experts on this subject based on the ideXlab platform.
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extractables and leachables issues with the application of single use technology in the Biopharmaceutical Industry
Journal of Chemical Technology & Biotechnology, 2016Co-Authors: Ying Gao, Nigel AllisonAbstract:Single-use technology has been adopted widely in bioprocess development and Biopharmaceutical manufacture in recent years. While the benefits of such technologies are well recognized, there are significant concerns regarding extractables and leachables arising from the components of single-use systems owing to their potential effect on product quality and patient health. Their impact on drug product quality and safety must be clearly understood before adopting disposable technologies into manufacture. A risk assessment is normally required to assess the probability of extractables and leachables migrating into the product stream and their potential risk to the patient. Generic information provided by suppliers may be useful but its relevance to individual applications needs to be demonstrated. Standardization of extractables and leachables testing and approaches to risk assessment has been discussed between the Biopharmaceutical Industry and regulators. This perspective reviews the current status of extractables and leachables studies within the Biopharmaceutical Industry and the general approaches employed for risk evaluation associated with the application of single-use technology. © 2015 Society of Chemical Industry
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Current status and future trends for disposable technology in the Biopharmaceutical Industry
Journal of Chemical Technology & Biotechnology, 2013Co-Authors: Nigel Allison, Jackie RichardsAbstract:Single use technology (SUT) is in widespread use throughout the Biopharmaceutical Industry where it is replacing traditional stainless steel plant particularly for the manufacture of small volume, high value products. The key drivers for SUT uptake include reduction of regulatory risk, lower capital and energy costs and increased facility flexibility. Disposable technology is now well established for cell culture, liquid handling and storage but its application to some downstream operations is proving more intractable. Single-use chromatography resins are generally uneconomic at process scale and there are limitations on large-scale tangential flow filtration capacities. The development of disposable sensor technology is lagging behind that of bioreactors and capacities for microbial culture are presently limited to 2000 litres. Concerns regarding compatibility of equipment from different suppliers and extractable and leachable testing are being addressed but continue to influence uptake of SUT by traditional manufacturers. Complete ‘plug and play’ disposable process trains, however, are becoming increasingly available and are being embraced by Contract Manufacturing Organisations (CMOs) with multiproduct facilities. © 2013 Society of Chemical Industry
Moritz Von Stosch - One of the best experts on this subject based on the ideXlab platform.
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Towards a widespread adoption of metabolic modeling tools in Biopharmaceutical Industry: a process systems biology engineering perspective
NPJ systems biology and applications, 2020Co-Authors: Anne Richelle, Blandine David, Didier Demaegd, Marianne Dewerchin, Romain Kinet, Angelo Morreale, Rui M. C. Portela, Quentin Zune, Moritz Von StoschAbstract:In biotechnology, the emergence of high-throughput technologies challenges the interpretation of large datasets. One way to identify meaningful outcomes impacting process and product attributes from large datasets is using systems biology tools such as metabolic models. However, these tools are still not fully exploited for this purpose in industrial context due to gaps in our knowledge and technical limitations. In this paper, key aspects restraining the routine implementation of these tools are highlighted in three research fields: monitoring, network science and hybrid modeling. Advances in these fields could expand the current state of systems biology applications in Biopharmaceutical Industry to address existing challenges in bioprocess development and improvement.
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hybrid modeling for quality by design and pat benefits and challenges of applications in Biopharmaceutical Industry
Biotechnology Journal, 2014Co-Authors: Moritz Von Stosch, Steven Davy, Kjell Francois, Vytautas Galvanauskas, Jan Martijn Hamelink, Andreas Luebbert, Martin Mayer, Rui Oliveira, Ronan Okennedy, Paul RiceAbstract:This report highlights the drivers, challenges, and enablers of the hybrid modeling applications in Biopharmaceutical Industry. It is a summary of an expert panel discussion of European academics and industrialists with relevant scientific and engineering backgrounds. Hybrid modeling is viewed in its broader sense, namely as the integration of different knowledge sources in form of parametric and nonparametric models into a hybrid semi-parametric model, for instance the integration of fundamental and data-driven models. A brief description of the current state-of-the-art and industrial uptake of the methodology is provided. The report concludes with a number of recommendations to facilitate further developments and a wider industrial application of this modeling approach. These recommendations are limited to further exploiting the benefits of this methodology within process analytical technology (PAT) applications in Biopharmaceutical Industry.
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Hybrid modeling for quality by design and PAT‐benefits and challenges of applications in Biopharmaceutical Industry
Biotechnology journal, 2014Co-Authors: Moritz Von Stosch, Steven Davy, Kjell Francois, Vytautas Galvanauskas, Jan Martijn Hamelink, Andreas Luebbert, Martin Mayer, Rui Oliveira, Ronan O'kennedy, Paul RiceAbstract:This report highlights the drivers, challenges, and enablers of the hybrid modeling applications in Biopharmaceutical Industry. It is a summary of an expert panel discussion of European academics and industrialists with relevant scientific and engineering backgrounds. Hybrid modeling is viewed in its broader sense, namely as the integration of different knowledge sources in form of parametric and nonparametric models into a hybrid semi-parametric model, for instance the integration of fundamental and data-driven models. A brief description of the current state-of-the-art and industrial uptake of the methodology is provided. The report concludes with a number of recommendations to facilitate further developments and a wider industrial application of this modeling approach. These recommendations are limited to further exploiting the benefits of this methodology within process analytical technology (PAT) applications in Biopharmaceutical Industry.
