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

doi:10.7324/JABB.2023.75320

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Abstract

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

Citation:

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. http://doi.org/10.7324/JABB.2023.75320

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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Reference

1. Hymavathi M, Sathish T, Brahmaiah P, Prakasham RS. Impact of carbon and nitrogen sources on L-asparaginase production by isolated Bacillus circulans (MTCC 8574): application of saturated Plackett- Burman design. Chem Biochem Eng Q 2010;24:473-80.
2. Sanghvi G, Bhimani K, Vaishnav D, Oza T, Dave G, Kunjadia P, et al. Mitigation of acrylamide by L-asparaginase from Bacillus subtilis KDPS1 and analysis of degradation products by HPLC and HPTLC. Springerplus 2016;5:533. https://doi.org/10.1186/s40064-016-2159-8
3. El-Naggar NEA, El-Ewasy SM, El-Shweihy NM. Microbial L-asparaginase as a potential therapeutic agent for the treatment of acute lymphoblastic leukemia: the pros and cons. Int J Pharmacol 2014;10:182-99. https://doi.org/10.3923/ijp.2014.182.199
4. El-Naggar NEA, Moawad H, El-Shweihy NM. Process development for scale-up production of a therapeutic L-asparaginase by Streptomyces brollosae NEAE-115 from shake flasks to bioreactor. Sci Rep 2019;9:13571. https://doi.org/10.1038/s41598-019-49709-6
5. El-Naggar NEA, El-Shweihy NM. Bioprocess development for L-asparaginase production by Streptomyces rochei, purification and in-vitro efficacy against various human carcinoma cell lines. Sci Rep 2020;10:7942. https://doi.org/10.1038/s41598-020-64052-x
6. Verma N, Kumar K, Kaur G, Anand S. L-asparaginase: a promising chemotherapeutic agent. Crit Rev Biotechnol J 2007;27:45-62. https://doi.org/10.1080/07388550601173926
7. Duval M, Suciu S, Ferster A, Rialland X, Nelken B, Lutz P, et al. Comparison of Escherichia coli-asparaginase with Erwinia-asparaginase in the treatment of childhood lymphoid malignancies: results of a randomized European organisation for research and treatment of cancer-children's leukemia group phase 3 trial. Blood 2002;99, 2734-9. https://doi.org/10.1182/blood.V99.8.2734
8. Pedreschi F, Kaack K, Granby K. The effect of asparaginase on acrylamide formation in French fries. Food Chem 2008;109:386-92. https://doi.org/10.1016/j.foodchem.2007.12.057
9. Savitri AN, Azmi W. Microbial L-asparaginase: a potent antitumour enzyme. Indian J Biotechnol 2003;2:184-94.
10. Hymavathi M, Sathish T, Rao CS, Prakasham RS. Enhancement of L-asparaginase production by isolated Bacillus circulans (MTCC 8574) using response surface methodology. Appl Biochem Biotechnol 2009;159:191-8. https://doi.org/10.1007/s12010-008-8438-2
11. Mukherjee R, Bera D. Statistical optimization of asparaginase production by a novel isolated bacterium Brevibacillus borstelensis ML12 using Plackett-Burman design and response surface methodology. J App Biol Biotech 2022;10(3):12-21. https://doi.org/10.7324/JABB.2022.100303
12. Deshpande N, Choubey P, Agashe M. Studies on optimization of growth parameters for L-asparaginase production by Streptomyces ginsengisoli. Sci World J 2014;29:895167. https://doi.org/10.1155/2014/895167
13. Mottram DS, Wedzicha BL, Dodson AT. Food chemistry: acrylamide is formed in the Maillard reaction. Nature 2002;419:448-9. https://doi.org/10.1038/419448a
14. Morales-Gonzalez M, Martinez BS, Rodriguez L, Gómez JEC, Diaz LE. Optimization of L-asparaginase activity of Actinobacteria isolated from Guaviare River sediments in Colombia. Trop J Pharm Res 2018;17:2199-206. https://doi.org/10.4314/tjpr.v17i11.13
15. Meena B, Anburajan L, Sathish T, Raghavan RV, Dharani G. L-asparaginase from Streptomyces griseus NIOT-VKMA29: optimization of process variables using factorial designs and molecular characterization of L asparaginase gene. Sci Rep 2015;5:12404. https://doi.org/10.1038/srep12404
16. Sathish T, Prakasham RS. Isolation and identification of L-glutaminase an antileukemic enzyme producing micro-organism from Godavari River bank soils in Andhra Pradesh. Int Res J Pharm 2010;1:367-73.
17. Sathish T, Prakasham RS. Enrichment of glutaminase production by Bacillus sp. RSP-GLU in submerged cultivation based on neural network-genetic algorithm approach. J Chem Technol Biotechnol 2010;85:50-8. https://doi.org/10.1002/jctb.2267
18. Sathish T, Prakasham RS. Modeling the effect of L-glutamine, aeration and agitation regimes on production of L-glutaminase in stirred tank reactor using Bacillus subtilis RSP-GLU. Int J Indus Biotechnol 2011;1:27-33.
19. Mahalakshmi Y, Sathish T, Subba Rao C, Prakasham RS. Corn husk as a novel substrate for enhanced production of rifamycin-B by isolated Amycolatopsis sp. RSP 3. Process Biochem 2010;45:47-53. https://doi.org/10.1016/j.procbio.2009.08.001
20. Kumar D, Batra J, Komives C, Rathore AS. QbD based media development for the production of fab fragments in E. coli. Bioengineering (Basel) 2019;6(2):29. https://doi.org/10.3390/bioengineering6020029
21. Rathore AS, Winkle H. Quality by design for biopharmaceuticals. Nat Biotechnol 2009;27:26. https://doi.org/10.1038/nbt0109-26
22. Rathore AS. Quality by design (QbD)-based process development for purification of a biotherapeutic. Trends Biotechnol 2016;34:358-70. https://doi.org/10.1016/j.tibtech.2016.01.003
23. ICH Harmonised Tripartite Guideline. Pharmaceutical development.
24. Rathore AS. QbD/PAT for bioprocessing: moving from theory to implementation. Curr Opin Chem Eng 2014;6:1-8. https://doi.org/10.1016/j.coche.2014.05.006
25. Sarquis MI, Oliveira EM, Santos AS, Costa GL. Production of L-asparaginase by filamentous fungi. Mem Inst Oswaldo Cruz 2004;99:489-92. https://doi.org/10.1590/S0074-02762004000500005
26. Sukumaran CP, Singh DV, Mahadevan PR. Synthesis of L-asparaginase by Serratia marcescens. J Biosci 1979;1:263-9. https://doi.org/10.1007/BF02716875
27. Boeck LD, Ho PPK. L-asparaginase production during static incubation of aerobically grown Escherichia coli B. Can J Microbiol 1973;19:1251-7. https://doi.org/10.1139/m73-202
28. De Jong PJ. L-asparaginase production by Streptomyces griseus. Appl Microbiol 1971;23:1163-4. https://doi.org/10.1128/am.23.6.1163-1164.1972
29. Heinemann B, Howard AJ. Production of tumor-inhibitory L-asparaginase by submerged growth of Serratia marcescens. Appl Microbiol 1969;18:550-4. https://doi.org/10.1128/am.18.4.550-554.1969
30. Cedar H, Schwartz JH. Production of L-asparaginase II by Escherichia coli. J Bacteriol 1968;96:2043-8. https://doi.org/10.1128/jb.96.6.2043-2048.1968
31. Abdel-Fattah YR, Olama, ZA. L-Asparaginase production by Pseudomonas aeruginosa in solid-state culture: evaluation and optimization of culture conditions using factorial designs. Process Biochem 2002;38:115-22. https://doi.org/10.1016/S0032-9592(02)00067-5
32. Khan AA, Pal SP, Raghavan SRV, Bhattacharyya PK. Studies on Serratia marcescens L-asparaginase. Biochem Biophy Res Commun 1970;41:525-33. https://doi.org/10.1016/0006-291X(70)90044-6
33. Liu FS, Zajic JE. Fermentation kinetics and continuous process of L-asparaginase production. Appl Microbiol 1973;25:92-6. https://doi.org/10.1128/am.25.1.92-96.1973
34. Peterson RE, Ciegler A. L-asparaginase production by Erwinia aroideae. Appl Microbiol 1969;18:64-7. https://doi.org/10.1128/am.18.1.64-67.1969
35. Paul JH, Cooksey KE. Regulation of asparaginase, glutamine synthetase, and glutamate dehydrogenase in response to medium nitrogen concentrations in a euryhaline Chlamydomonas sp. Plant Physiol 1981;68:1364-8. https://doi.org/10.1104/pp.68.6.1364
36. Sathish T, Uppuluri KB, Bramhachari PV, Kezia D. Sequential optimization methods for augmentation of marine enzymes production in solid-state fermentation: L-glutaminase production a case study. In: Kim S, Toldrá F (eds.). Advances in food and nutrition research, Academic Press, Cambridge, MA, vol. 78, pp 95-114, 2016. https://doi.org/10.1016/bs.afnr.2016.06.003
37. Chiranjeevi PV, Pandian MR, Sathish T. Enhancement of laccase production from Pleurotus ostreatus PVCRSP-7 by altering the nutritional conditions using response surface methodology. Bioresour Technol 2014;9(3):4212-25. https://doi.org/10.15376/biores.9.3.4212-4225
38. Sathish T, Kezia D, Bramhachari PV, Prakasham RS. Multi-objective based superimposed optimization method for enhancement of L-glutaminase production by Bacillus subtilis RSP-GLU. Karbala Int J Modern Sci 2018;4:50-60. https://doi.org/10.1016/j.kijoms.2017.10.006
39. Kumar K, Verma N. The various sources and application of L asparaginase. Asian J Biochem Pharm Res 2012;2:197-205.
40. Shakambari G, Sumi BM, Ashokkumar B, Peramachi P, Perumal V. Industrial effluent as a substrate for glutaminase free. L-asparaginase production from Pseudomonas plecoglossicida strain RS1; media optimization, enzyme purification and its characterization. RSC Adv 2015;5:48729-38. https://doi.org/10.1039/C5RA05507E
41. Mangamuri U, Vijayalakshmi M, Ganduri VSRK, Babu S, Poda RS. Extracellular L-asparaginase from Streptomyces labedae VSM-6: isolation, production and optimization of culture conditions using RSM. Pharmacog J 2017;9:931-40. https://doi.org/10.5530/pj.2017.6.146
42. Rajamanickam U, Mala KK, Venil CK, Palaniswamy M. Screening of actinomycetes from mangrove ecosystem for L-asparaginase activity and optimization by response surface methodology. Polish J Microbiol 2011;60:213-21. https://doi.org/10.33073/pjm-2011-030
43. Prakasham RS, Rao CS, Rao RS, Sarma PN. L-asparaginase production by Staphylococcus sp.-6A: design of experiment considering interaction effect for process parameter optimization. J Appl Microbiol 2007;102:1382-91. https://doi.org/10.1111/j.1365-2672.2006.03173.x

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Velisetty T R [PubMed] [Google Scholar ]

Thadikamala S [PubMed] [Google Scholar ]

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By article title

1. Hymavathi M, Sathish T, Brahmaiah P, Prakasham RS. Impact of carbon and nitrogen sources on L-asparaginase production by isolated Bacillus circulans (MTCC 8574): application of saturated Plackett- Burman design. Chem Biochem Eng Q 2010;24:473-80.

2. Sanghvi G, Bhimani K, Vaishnav D, Oza T, Dave G, Kunjadia P, et al. Mitigation of acrylamide by L-asparaginase from Bacillus subtilis KDPS1 and analysis of degradation products by HPLC and HPTLC. Springerplus 2016;5:533. https://doi.org/10.1186/s40064-016-2159-8

3. El-Naggar NEA, El-Ewasy SM, El-Shweihy NM. Microbial L-asparaginase as a potential therapeutic agent for the treatment of acute lymphoblastic leukemia: the pros and cons. Int J Pharmacol 2014;10:182-99. https://doi.org/10.3923/ijp.2014.182.199

4. El-Naggar NEA, Moawad H, El-Shweihy NM. Process development for scale-up production of a therapeutic L-asparaginase by Streptomyces brollosae NEAE-115 from shake flasks to bioreactor. Sci Rep 2019;9:13571. https://doi.org/10.1038/s41598-019-49709-6

5. El-Naggar NEA, El-Shweihy NM. Bioprocess development for L-asparaginase production by Streptomyces rochei, purification and in-vitro efficacy against various human carcinoma cell lines. Sci Rep 2020;10:7942. https://doi.org/10.1038/s41598-020-64052-x

6. Verma N, Kumar K, Kaur G, Anand S. L-asparaginase: a promising chemotherapeutic agent. Crit Rev Biotechnol J 2007;27:45-62. https://doi.org/10.1080/07388550601173926

7. Duval M, Suciu S, Ferster A, Rialland X, Nelken B, Lutz P, et al. Comparison of Escherichia coli-asparaginase with Erwinia-asparaginase in the treatment of childhood lymphoid malignancies: results of a randomized European organisation for research and treatment of cancer-children's leukemia group phase 3 trial. Blood 2002;99, 2734-9. https://doi.org/10.1182/blood.V99.8.2734

8. Pedreschi F, Kaack K, Granby K. The effect of asparaginase on acrylamide formation in French fries. Food Chem 2008;109:386-92. https://doi.org/10.1016/j.foodchem.2007.12.057

9. Savitri AN, Azmi W. Microbial L-asparaginase: a potent antitumour enzyme. Indian J Biotechnol 2003;2:184-94.

10. Hymavathi M, Sathish T, Rao CS, Prakasham RS. Enhancement of L-asparaginase production by isolated Bacillus circulans (MTCC 8574) using response surface methodology. Appl Biochem Biotechnol 2009;159:191-8. https://doi.org/10.1007/s12010-008-8438-2

11. Mukherjee R, Bera D. Statistical optimization of asparaginase production by a novel isolated bacterium Brevibacillus borstelensis ML12 using Plackett-Burman design and response surface methodology. J App Biol Biotech 2022;10(3):12-21. https://doi.org/10.7324/JABB.2022.100303

12. Deshpande N, Choubey P, Agashe M. Studies on optimization of growth parameters for L-asparaginase production by Streptomyces ginsengisoli. Sci World J 2014;29:895167. https://doi.org/10.1155/2014/895167

13. Mottram DS, Wedzicha BL, Dodson AT. Food chemistry: acrylamide is formed in the Maillard reaction. Nature 2002;419:448-9. https://doi.org/10.1038/419448a

14. Morales-Gonzalez M, Martinez BS, Rodriguez L, Gómez JEC, Diaz LE. Optimization of L-asparaginase activity of Actinobacteria isolated from Guaviare River sediments in Colombia. Trop J Pharm Res 2018;17:2199-206. https://doi.org/10.4314/tjpr.v17i11.13

15. Meena B, Anburajan L, Sathish T, Raghavan RV, Dharani G. L-asparaginase from Streptomyces griseus NIOT-VKMA29: optimization of process variables using factorial designs and molecular characterization of L asparaginase gene. Sci Rep 2015;5:12404. https://doi.org/10.1038/srep12404

16. Sathish T, Prakasham RS. Isolation and identification of L-glutaminase an antileukemic enzyme producing micro-organism from Godavari River bank soils in Andhra Pradesh. Int Res J Pharm 2010;1:367-73.

17. Sathish T, Prakasham RS. Enrichment of glutaminase production by Bacillus sp. RSP-GLU in submerged cultivation based on neural network-genetic algorithm approach. J Chem Technol Biotechnol 2010;85:50-8. https://doi.org/10.1002/jctb.2267

18. Sathish T, Prakasham RS. Modeling the effect of L-glutamine, aeration and agitation regimes on production of L-glutaminase in stirred tank reactor using Bacillus subtilis RSP-GLU. Int J Indus Biotechnol 2011;1:27-33.

19. Mahalakshmi Y, Sathish T, Subba Rao C, Prakasham RS. Corn husk as a novel substrate for enhanced production of rifamycin-B by isolated Amycolatopsis sp. RSP 3. Process Biochem 2010;45:47-53. https://doi.org/10.1016/j.procbio.2009.08.001

20. Kumar D, Batra J, Komives C, Rathore AS. QbD based media development for the production of fab fragments in E. coli. Bioengineering (Basel) 2019;6(2):29. https://doi.org/10.3390/bioengineering6020029

21. Rathore AS, Winkle H. Quality by design for biopharmaceuticals. Nat Biotechnol 2009;27:26. https://doi.org/10.1038/nbt0109-26

22. Rathore AS. Quality by design (QbD)-based process development for purification of a biotherapeutic. Trends Biotechnol 2016;34:358-70. https://doi.org/10.1016/j.tibtech.2016.01.003

23. ICH Harmonised Tripartite Guideline. Pharmaceutical development.

24. Rathore AS. QbD/PAT for bioprocessing: moving from theory to implementation. Curr Opin Chem Eng 2014;6:1-8. https://doi.org/10.1016/j.coche.2014.05.006

25. Sarquis MI, Oliveira EM, Santos AS, Costa GL. Production of L-asparaginase by filamentous fungi. Mem Inst Oswaldo Cruz 2004;99:489-92. https://doi.org/10.1590/S0074-02762004000500005

26. Sukumaran CP, Singh DV, Mahadevan PR. Synthesis of L-asparaginase by Serratia marcescens. J Biosci 1979;1:263-9. https://doi.org/10.1007/BF02716875

27. Boeck LD, Ho PPK. L-asparaginase production during static incubation of aerobically grown Escherichia coli B. Can J Microbiol 1973;19:1251-7. https://doi.org/10.1139/m73-202

28. De Jong PJ. L-asparaginase production by Streptomyces griseus. Appl Microbiol 1971;23:1163-4. https://doi.org/10.1128/am.23.6.1163-1164.1972

29. Heinemann B, Howard AJ. Production of tumor-inhibitory L-asparaginase by submerged growth of Serratia marcescens. Appl Microbiol 1969;18:550-4. https://doi.org/10.1128/am.18.4.550-554.1969

30. Cedar H, Schwartz JH. Production of L-asparaginase II by Escherichia coli. J Bacteriol 1968;96:2043-8. https://doi.org/10.1128/jb.96.6.2043-2048.1968

31. Abdel-Fattah YR, Olama, ZA. L-Asparaginase production by Pseudomonas aeruginosa in solid-state culture: evaluation and optimization of culture conditions using factorial designs. Process Biochem 2002;38:115-22. https://doi.org/10.1016/S0032-9592(02)00067-5

32. Khan AA, Pal SP, Raghavan SRV, Bhattacharyya PK. Studies on Serratia marcescens L-asparaginase. Biochem Biophy Res Commun 1970;41:525-33. https://doi.org/10.1016/0006-291X(70)90044-6

33. Liu FS, Zajic JE. Fermentation kinetics and continuous process of L-asparaginase production. Appl Microbiol 1973;25:92-6. https://doi.org/10.1128/am.25.1.92-96.1973

34. Peterson RE, Ciegler A. L-asparaginase production by Erwinia aroideae. Appl Microbiol 1969;18:64-7. https://doi.org/10.1128/am.18.1.64-67.1969

35. Paul JH, Cooksey KE. Regulation of asparaginase, glutamine synthetase, and glutamate dehydrogenase in response to medium nitrogen concentrations in a euryhaline Chlamydomonas sp. Plant Physiol 1981;68:1364-8. https://doi.org/10.1104/pp.68.6.1364

36. Sathish T, Uppuluri KB, Bramhachari PV, Kezia D. Sequential optimization methods for augmentation of marine enzymes production in solid-state fermentation: L-glutaminase production a case study. In: Kim S, Toldrá F (eds.). Advances in food and nutrition research, Academic Press, Cambridge, MA, vol. 78, pp 95-114, 2016. https://doi.org/10.1016/bs.afnr.2016.06.003

37. Chiranjeevi PV, Pandian MR, Sathish T. Enhancement of laccase production from Pleurotus ostreatus PVCRSP-7 by altering the nutritional conditions using response surface methodology. Bioresour Technol 2014;9(3):4212-25. https://doi.org/10.15376/biores.9.3.4212-4225

38. Sathish T, Kezia D, Bramhachari PV, Prakasham RS. Multi-objective based superimposed optimization method for enhancement of L-glutaminase production by Bacillus subtilis RSP-GLU. Karbala Int J Modern Sci 2018;4:50-60. https://doi.org/10.1016/j.kijoms.2017.10.006

39. Kumar K, Verma N. The various sources and application of L asparaginase. Asian J Biochem Pharm Res 2012;2:197-205.

40. Shakambari G, Sumi BM, Ashokkumar B, Peramachi P, Perumal V. Industrial effluent as a substrate for glutaminase free. L-asparaginase production from Pseudomonas plecoglossicida strain RS1; media optimization, enzyme purification and its characterization. RSC Adv 2015;5:48729-38. https://doi.org/10.1039/C5RA05507E

41. Mangamuri U, Vijayalakshmi M, Ganduri VSRK, Babu S, Poda RS. Extracellular L-asparaginase from Streptomyces labedae VSM-6: isolation, production and optimization of culture conditions using RSM. Pharmacog J 2017;9:931-40. https://doi.org/10.5530/pj.2017.6.146

42. Rajamanickam U, Mala KK, Venil CK, Palaniswamy M. Screening of actinomycetes from mangrove ecosystem for L-asparaginase activity and optimization by response surface methodology. Polish J Microbiol 2011;60:213-21. https://doi.org/10.33073/pjm-2011-030

43. Prakasham RS, Rao CS, Rao RS, Sarma PN. L-asparaginase production by Staphylococcus sp.-6A: design of experiment considering interaction effect for process parameter optimization. J Appl Microbiol 2007;102:1382-91. https://doi.org/10.1111/j.1365-2672.2006.03173.x