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Application of process analytical technology for downstream purification of biotherapeutics
Author(s) -
Rathore Anurag S.,
Kapoor Gautam
Publication year - 2015
Publication title -
journal of chemical technology and biotechnology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.64
H-Index - 117
eISSN - 1097-4660
pISSN - 0268-2575
DOI - 10.1002/jctb.4447
Subject(s) - downstream (manufacturing) , robustness (evolution) , process analytical technology , process (computing) , downstream processing , biochemical engineering , process engineering , manufacturing engineering , quality (philosophy) , computer science , product (mathematics) , risk analysis (engineering) , work in process , raw material , engineering , operations management , business , chemistry , mathematics , chromatography , biochemistry , philosophy , geometry , organic chemistry , epistemology , gene , operating system
The concept of Process Analytical Technology ( PAT ) introduced by the US FDA has received a lot of attention lately. The use of such a scheme ensures robust process performance over the entire life cycle of the product and consistent product quality at the end of the manufacturing process. Successful implementation of PAT requires use of high resolution, orthogonal analytical tools that are able to measure the critical quality attributes ( CQA ) of the raw materials and in‐process materials with the aim of ensuring final product quality. This article presents a review of PAT applications for monitoring commonly used downstream biotech unit operations. Focus of the review will be on recent advancements (last 5 years). Analytical tools that have been used in these approaches have also been discussed with reference to their speed of analysis, robustness and sensitivity. Also discussed is their potential to replace the traditional high performance liquid chromatography ( HPLC ) which continues to be the gold standard for analysis of biotech therapeutics. © 2014 Society of Chemical Industry