Research Article | Volume 11, Issue 5, September, 2023

Quality by design approach implementation in media development for the production of therapeutic enzyme

Tharaka Rama Velisetty Sathish Thadikamala Chiranjeevi Potu Sudhakar Poda Krishna Satya Alapati   

Open Access   

Published:  Aug 10, 2023

DOI: 10.7324/JABB.2023.75320

L-asparaginase is a highly demanding therapeutic enzyme. This enzyme has wide applications in food, therapeutic, and biosensor industries. Since L-asparaginase is a chemotherapeutic agent/enzyme, it is important to maintain the final product quality. Nowadays, FDA and other regulatory authorities emphasize having quality by design (QbD) based product development. Because of this requirement, QbD principles were implemented in this study for optimization of the L-asparaginase production by Bacillus subtilis THARAKA. QbD was implemented through the design of the experiment strategy. Initially, the Plackett–Burman design (PBD) was used to screen the nutrients which have a significant effect on the enzyme. Among 11 studied nutrients, 3 components glucose, L-asparagine, and (NH4)2SO4 were screened by using PBD, and their concentrations were further optimized by using response surface methodology. Screened nutrients and process parameters were optimized using the central composite design (CCD). By sequential optimization methods such as PBD followed by CCD a 28% L-asparaginase production was enhanced.

Keyword:     L-Asparaginase quality by design (QbD) Plackett–Burman design (PBD) central composite design (CCD) enzyme Bacillus subtilis


Thadikamala S, Velisetty TR, Potu C, Sudhakar P, Alapati KS. Quality by design approach implementation in media development for the production of therapeutic enzyme. J Appl Biol Biotech 2023; 11(05):221–231.

Copyright: Author(s). This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike license.

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