Chromatographic elution process design space development for the purification of saponins in Panax notoginseng extract using a probability-based approach

2015 ◽  
Vol 39 (2) ◽  
pp. 306-315 ◽  
Author(s):  
Teng Chen ◽  
Xingchu Gong ◽  
Huali Chen ◽  
Ying Zhang ◽  
Haibin Qu
Keyword(s):  
Process Design ◽  
Design Space ◽  
Panax Notoginseng ◽  
Chromatographic Elution

scholarly journals A Novel Framework to Aid the Development of Design Space across Multi-Unit Operation Pharmaceutical Processes—A Case Study of Panax Notoginseng Saponins Immediate Release Tablet

Pharmaceutics ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 474 ◽  
Author(s):  
Fei Sun ◽  
Bing Xu ◽  
Shengyun Dai ◽  
Yi Zhang ◽  
Zhaozhou Lin ◽  
...  
Keyword(s):  
Process Modeling ◽  
Design Space ◽  
Panax Notoginseng ◽  
Immediate Release ◽  
Path Model ◽  
Unit Operation ◽  
Panax Notoginseng Saponins ◽  
Holistic View ◽  
Unit Operations ◽  
Release Tablet

The fundamental principle of Quality by Design (QbD) is that the product quality should be designed into the process through an upstream approach, rather than be tested in the downstream. The keystone of QbD is process modeling, and thus, to develop a process control strategy based on the development of design space. Multivariate statistical analysis is a very useful tool to support the implementation of QbD in pharmaceutical process development and manufacturing. Nowadays, pharmaceutical process modeling is mainly focused on one-unit operations and system modeling for the development of design space across multi-unit operations is still limited. In this study, a general procedure that gives a holistic view for understanding and controlling the process settings for the entire manufacturing process was investigated. The proposed framework was tested on the Panax Notoginseng Saponins immediate release tablet (PNS IRT) production process. The critical variables and the critical units acting on the process were identified according to the importance of explaining the variability in the multi-block partial least squares path model. This improved understanding of the process by illustrating how the properties of the raw materials, the process parameters in the wet granulation and the compaction and the intermediate properties affect the tablet properties. Furthermore, the design space was developed to compensate for the variability source from the upstream. The results demonstrated that the proposed framework was an important tool to gain understanding and control the multi-unit operation process.

scholarly journals The Business Process Design Space for exploring process redesign alternatives

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Steven Gross ◽  
Katharina Stelzl ◽  
Thomas Grisold ◽  
Jan Mendling ◽  
Maximilian Röglinger ◽  
...  
Keyword(s):  
Conceptual Model ◽  
Business Process ◽  
Real World ◽  
Process Design ◽  
Business Processes ◽  
Design Space ◽  
Business Process Design ◽  
Content Type ◽  
Process Redesign ◽  
Design Alternatives

PurposeProcess redesign refers to the intentional change of business processes. While process redesign methods provide structure to redesign projects, they provide limited support during the actual creation of to-be processes. More specifically, existing approaches hardly develop an ontological perspective on what can be changed from a process design point of view, and they provide limited procedural guidance on how to derive possible process design alternatives. This paper aims to provide structured guidance during the to-be process creation.Design/methodology/approachUsing design space exploration as a theoretical lens, the authors develop a conceptual model of the design space for business processes, which facilitates the systematic exploration of design alternatives along different dimensions. The authors utilized an established method for taxonomy development for constructing the conceptual model. First, the authors derived design dimensions for business processes and underlying characteristics through a literature review. Second, the authors conducted semi-structured interviews with professional process experts. Third, the authors evaluated their artifact through three real-world applications.FindingsThe authors identified 19 business process design dimensions that are grouped into different layers and specified by underlying characteristics. Guiding questions and illustrative real-world examples help to deploy these design dimensions in practice. Taken together, the design dimensions form the “Business Process Design Space” (BPD-Space).Research limitations/implicationsPractitioners can use the BPD-Space to explore, question and rethink business processes in various respects.Originality/valueThe BPD-Space complements existing approaches by explicating process design dimensions. It abstracts from specific process flows and representations of processes and supports an unconstrained exploration of various alternative process designs.

Defining process design space for monoclonal antibody cell culture

2010 ◽  
Vol 106 (6) ◽  
pp. 894-905 ◽  
Author(s):  
Susan Fugett Abu-Absi ◽  
LiYing Yang ◽  
Patrick Thompson ◽  
Canping Jiang ◽  
Sunitha Kandula ◽  
...  
Keyword(s):  
Cell Culture ◽  
Monoclonal Antibody ◽  
Process Design ◽  
Design Space
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