设计质量
稳健性(进化)
大小排阻色谱法
生化工程
工艺工程
质量(理念)
色谱法
计算机科学
化学
工程类
粒径
物理
生物化学
物理化学
量子力学
基因
酶
作者
Sabya Sachi Das,Priya Ranjan Prasad Verma,Shubhankar Kumar Singh,Neeru Singh,Sandeep Kumar Singh
出处
期刊:Elsevier eBooks
[Elsevier]
日期:2021-01-01
卷期号:: 71-85
标识
DOI:10.1016/b978-0-12-820332-3.00004-2
摘要
The analytical quality by design (A-QbD) approach includes the concept of practical use of QbD into the development of analytical methods. Nowadays, because of the robustness of method, the pharmaceutical and biotech companies have shown much consideration over A-QbD as compared to the conventional approaches. Moreover, the implementation of A-QbD by the pharmaceutical and biotech industries has become a trend for process and method development to regulate the risk management and maintain the quality of products. Moreover, the application of A-QbD in chromatographic techniques such as size-exclusion chromatography (SEC) has increased the quality and yield of products. SEC is one of the most prevalent methods used to separate, measure, and quantify the average molecular weight of various products, mostly macromolecules. In combination, SEC and A-QbD have been used as a vital analytical approach for characterization and quantification of various types of bio-macromolecules. In this chapter, we have summarized various A-QbD-based approaches used in the establishment of SEC parameters for effective quantification and assessment of pharmaceutical products or biologicals.
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