Quality by Design (QbD)-Based Crystallization Process Development for the Polymorphic Drug Tolbutamide

2011 ◽  
Vol 11 (7) ◽  
pp. 3027-3038 ◽  
Author(s):  
Satyanarayana Thirunahari ◽  
Pui Shan Chow ◽  
Reginald B. H. Tan
Keyword(s):  
Quality By Design ◽  
Crystallization Process ◽  
Process Development

Process development in the Quality by Design paradigm: Modeling of Protein A chromatography resin fouling

2018 ◽  
Vol 1570 ◽  
pp. 56-66 ◽  
Author(s):  
Lalita Kanwar Shekhawat ◽  
Mili Pathak ◽  
Jayati Sakar ◽  
Anurag S. Rathore
Keyword(s):  
Quality By Design ◽  
Process Development ◽  
Protein A ◽  
Design Paradigm

scholarly journals Distinct and Quantitative Validation for Predictive Process Modelling in Steam Distillation of Caraway Fruits and Lavender Flower Following a Quality-By-Design (QbD) Approach

Processes ◽  
2020 ◽  
Vol 8 (5) ◽  
pp. 594 ◽  
Author(s):  
Thorsten Roth ◽  
Lukas Uhlenbrock ◽  
Jochen Strube
Keyword(s):  
Quality By Design ◽  
Steam Distillation ◽  
Process Development ◽  
Model Development ◽  
Chemical Model ◽  
Maximum Information ◽  
Physico Chemical ◽  
Target Values ◽  
Different Types ◽  
Quantitative Validation

A quality by design (QbD) approach as part of process development in the regulated, pharmaceutical industry requires many experiments. Due to the large number, process development is time consuming and cost intensive. A key to modern process development to reduce the number of required experiments is a predictive simulation with a validated physico-chemical model. In order to expand the process expertise of steam distillation through maximum information, a model development workflow is used in this paper, which focuses on implementation, verification, parametrization and validation of a physico-chemical model. Process robustness and sensitivity of target values can be determined from the developed general model and design of experiments with statistical evaluations. The model validation is exemplified by two different types of plant systems, caraway fruits (Carum Carvi) and lavender flowers (Lavandula).

Quality by Design-Driven Process Development of Cell Culture in Bioreactor for the Production of Foot-And-Mouth Veterinary Vaccine

2019 ◽  
Vol 108 (7) ◽  
pp. 2288-2295 ◽  
Author(s):  
Xinran Li ◽  
Xuerong Liu ◽  
Rongbin Wang ◽  
Fanglan An ◽  
Jianqi Nie ◽  
...  
Keyword(s):  
Cell Culture ◽  
Quality By Design ◽  
Process Development ◽  
Veterinary Vaccine ◽  
Foot And Mouth

Quality by design case study: An integrated multivariate approach to drug product and process development

2009 ◽  
Vol 382 (1-2) ◽  
pp. 23-32 ◽  
Author(s):  
Jun Huang ◽  
Goldi Kaul ◽  
Chunsheng Cai ◽  
Ramarao Chatlapalli ◽  
Pedro Hernandez-Abad ◽  
...  
Keyword(s):  
Quality By Design ◽  
Process Development ◽  
Drug Product ◽  
Multivariate Approach ◽  
Design Case ◽  
Product And Process ◽  
Design Case Study

scholarly journals Application of Quality by Design to the Process Development of Botanical Drug Products: A Case Study

2013 ◽  
Vol 14 (1) ◽  
pp. 277-286 ◽  
Author(s):  
Lei Zhang ◽  
Binjun Yan ◽  
Xingchu Gong ◽  
Lawrence X. Yu ◽  
Haibin Qu
Keyword(s):  
Quality By Design ◽  
Process Development ◽  
Drug Products ◽  
Botanical Drug
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