Proposing a Local “Technology Readiness Assessment” Model for Biopharmaceutical Industries of Iran
,
Abstract
Background: Reliable assessment of innovative technology readiness is crucial for industrial decision-making. Technology Readiness Assessment (TRA) is an established tool used to qualify technology development and help make investment decisions and deploy systems or technology elements to an end-user in a timely fashion. “Manufacturing readiness levels” (MRLs) and “ATLAS technology method” (technology components evaluation) metrics are commonly employed in TRA to assess the impact of technologies for future R&D programs and development of manufacturing and risk of a given technology, system, and or subsystem. Methods: In this study, E.coli-based recombinants were chosen as the objective. Two questionnaires were designed on their manufacturing process and sent to 13 biopharmaceutical experts in Iran. Results: The findings show that Iranian biopharmaceutical experts validated the proposed MRLs model inspired by the US Department of Defense’s published questionnaire. To run the “ATLAS technology method”, the relative importance of technology components (software, hardware, and human resources) involved in each stage of manufacturing and each stage’s relative importance was determined by experts in the percentage scale. Conclusion: Policymakers and managers must have enough knowledge of how to evaluate manufacturers’ abilities, and in this way, TRA is a usable and exquisite tool. In this article, two TRA methods that appear compatible with Iran’s environment of the biopharmaceutical sector are proposed.
[1] Rozycka M, Collins N, Stratton MR, Wooster R. Rapid detection of DNA sequence variants by conformation-sensitive capillary electrophoresis. Genomics. 2000; 70(1):34-40. [DOI:10.1006/geno.2000.6354] [PMID]
[2] McGarvey D, Olson J, Savitz S, Diaz G, Thompson G. Department of homeland security science and technology readiness level calculator (ver. 1.1). Arlington, USA: Homeland Security Studies and Analysis Institute; 2009. https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=Department+of+Homeland+Security+Science+and
+Technology+Readiness+Level+Calculator+&btnG=
[3] Krahn S, Sutter H, Johnson H. New developments in the technology readiness assessment process in US DOE-EM-13247. WM2013: Waste Management Conference: International Collaboration and Continuous Improvement. 24-28 February 2013; Phoenix, United States. https://www.osti.gov/biblio/22224997
[4] DoD US. Department of Defense: Technology Readiness Assessment (TRA) Guidance [Internet]. 2011. Available from: https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=Department+of+Defense%3A+Technology+readiness+assessment+%28TRA%29+Guidance&btnG=
[5] Dion-Schwarz C. How the department of defense uses technology readiness levels [Internet]. 2008. Available from: https://myclass.dau.edu/bbcswebdav/institution/Courses/Deployed/.pdf
[6] Guston DH, Sarewitz D. Real-time technology assessment. Technol Soc. 2002; 24(1-2):93-109.[DOI:10.1016/S0160-791X(01)00047-1]
[7] Daim TU, Intarode N. A framework for technology assessment: Case of a Thai building material manufacturer. Energy Sustain Dev. 2009; 13(4):280-6. [DOI:10.1016/j.esd.2009.10.006]
[8] Mokhtari Moghari M, Hoshmandzadeh MR. [An overview of technology evaluation, models and methods. national conference on the third millennium and humanities (Persian)]. Paper presented at: National Conference on the Third Millennium and Humanities. 6 June 2015; Shiraz, Iran. https://civilica.com/l/5835/
[9] den Hengst M, Herder PM. Quick and dirty’modeling in a decision support tool for supply chain design. Paper presented at: 2004 IEEE International Conference on Systems, Man and Cybernetics (IEEE Cat. No. 04CH37583). 10-13 October 2004; Hague, Netherlands. [DOI:10.1109/ICSMC.2004.1401247]
[10] Chou CL. A proposed approach to assess supply chain risks to meet the new challenges in the Defense industry [Msc. thesis]. Cambridge: Massachusetts Institute of Technology; 2012. http://hdl.handle.net/1721./73379
[11] Afshari-Mofrad M, Salim A. Iranian firms in biopharmaceutical value chain: Where to go now? J Sci Technol Policy Manage. 2019; 11(1):49-63. [DOI:10.1108/JSTPM-12-2018-0123]
[12] Schumann W, Ferreira LCS. Production of recombinant proteins in Escherichia coli. Genetics and Molecular Biology. 2004; 27(3):442-53. [DOI:10.1590/S1415-47572004000300022]
[13] Jozala AF, Geraldes DC, Tundisi LL, de Araújo Feitosa V, Breyer CA, Cardoso SL, et al. Biopharmaceuticals from microorganisms: From production to purification. Braz J Microbiol. 2016; 47(Suppl 1):51-63. [DOI:10.1016/j.bjm.2016.10.007] [PMID] [PMCID]
[14] Hebenbrock K, Schügerl K, Freitag R. Analysis of plasmid-DNA and cell protein of recombinant Escherichia coli using capillary gel electrophoresis. Electrophoresis. 1993; 14(8):753-8. [DOI:10.1002/elps.11501401118] [PMID]
[15] Mach H, Sanyal G, Volkin DB, Middaugh CR. Applications of ultraviolet absorption spectroscopy to the analysis of biopharmaceuticals. ACS Publications; 1997; 675:186-205. [DOI:10.1021/bk-1997-0675.ch011]
[16] Sheth JP, Qin Y, Sirkar KK, Baltzis BC. Nanofiltration-based diafiltration process for solvent exchange in pharmaceutical manufacturing. J Membr Sci. 2003; 211(2):251-61. [DOI:10.1016/S0376-7388(02)00423-4]
[17] Dehkordi AM. Application of a novel-opposed-jets contacting device in liquid-liquid extraction. Chem Eng Process. 2002; 41(3):251-8. [DOI:10.1016/S0255-2701(01)00141-6]
[18] Kasper JC, Friess W. The freezing step in lyophilization: Physicochemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals. Eur J Pharm Biopharm. 2011; 78(2):248-63. [DOI:10.1016/j.ejpb.2011.03.010] [PMID]
[19] Jameel F, Hershenson S. Formulation and process development strategies for manufacturing biopharmaceuticals. Hoboken: John Wiley & Sons; 2010. [DOI:10.1002/9780470595886]
[20] Subramanian G. Biopharmaceutical production technology. Hoboken: John Wiley & Sons; 2012. [DOI:10.1002/9783527653096]
[21] Wilson FR, Pan W, Schumsky DA. Recalculation of the critical values for Lawshe’s content validity ratio. Meas Eval Couns Dev. 2012; 45(3):197-210. [DOI:10.1177/0748175612440286]
[22] Fong PSW, Choi SKY. Final contractor selection using the analytical hierarchy process. Constr Manage Econ. 2000; 18(5):547-57.[DOI:10.1080/014461900407356]
[2] McGarvey D, Olson J, Savitz S, Diaz G, Thompson G. Department of homeland security science and technology readiness level calculator (ver. 1.1). Arlington, USA: Homeland Security Studies and Analysis Institute; 2009. https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=Department+of+Homeland+Security+Science+and
+Technology+Readiness+Level+Calculator+&btnG=
[3] Krahn S, Sutter H, Johnson H. New developments in the technology readiness assessment process in US DOE-EM-13247. WM2013: Waste Management Conference: International Collaboration and Continuous Improvement. 24-28 February 2013; Phoenix, United States. https://www.osti.gov/biblio/22224997
[4] DoD US. Department of Defense: Technology Readiness Assessment (TRA) Guidance [Internet]. 2011. Available from: https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=Department+of+Defense%3A+Technology+readiness+assessment+%28TRA%29+Guidance&btnG=
[5] Dion-Schwarz C. How the department of defense uses technology readiness levels [Internet]. 2008. Available from: https://myclass.dau.edu/bbcswebdav/institution/Courses/Deployed/.pdf
[6] Guston DH, Sarewitz D. Real-time technology assessment. Technol Soc. 2002; 24(1-2):93-109.[DOI:10.1016/S0160-791X(01)00047-1]
[7] Daim TU, Intarode N. A framework for technology assessment: Case of a Thai building material manufacturer. Energy Sustain Dev. 2009; 13(4):280-6. [DOI:10.1016/j.esd.2009.10.006]
[8] Mokhtari Moghari M, Hoshmandzadeh MR. [An overview of technology evaluation, models and methods. national conference on the third millennium and humanities (Persian)]. Paper presented at: National Conference on the Third Millennium and Humanities. 6 June 2015; Shiraz, Iran. https://civilica.com/l/5835/
[9] den Hengst M, Herder PM. Quick and dirty’modeling in a decision support tool for supply chain design. Paper presented at: 2004 IEEE International Conference on Systems, Man and Cybernetics (IEEE Cat. No. 04CH37583). 10-13 October 2004; Hague, Netherlands. [DOI:10.1109/ICSMC.2004.1401247]
[10] Chou CL. A proposed approach to assess supply chain risks to meet the new challenges in the Defense industry [Msc. thesis]. Cambridge: Massachusetts Institute of Technology; 2012. http://hdl.handle.net/1721./73379
[11] Afshari-Mofrad M, Salim A. Iranian firms in biopharmaceutical value chain: Where to go now? J Sci Technol Policy Manage. 2019; 11(1):49-63. [DOI:10.1108/JSTPM-12-2018-0123]
[12] Schumann W, Ferreira LCS. Production of recombinant proteins in Escherichia coli. Genetics and Molecular Biology. 2004; 27(3):442-53. [DOI:10.1590/S1415-47572004000300022]
[13] Jozala AF, Geraldes DC, Tundisi LL, de Araújo Feitosa V, Breyer CA, Cardoso SL, et al. Biopharmaceuticals from microorganisms: From production to purification. Braz J Microbiol. 2016; 47(Suppl 1):51-63. [DOI:10.1016/j.bjm.2016.10.007] [PMID] [PMCID]
[14] Hebenbrock K, Schügerl K, Freitag R. Analysis of plasmid-DNA and cell protein of recombinant Escherichia coli using capillary gel electrophoresis. Electrophoresis. 1993; 14(8):753-8. [DOI:10.1002/elps.11501401118] [PMID]
[15] Mach H, Sanyal G, Volkin DB, Middaugh CR. Applications of ultraviolet absorption spectroscopy to the analysis of biopharmaceuticals. ACS Publications; 1997; 675:186-205. [DOI:10.1021/bk-1997-0675.ch011]
[16] Sheth JP, Qin Y, Sirkar KK, Baltzis BC. Nanofiltration-based diafiltration process for solvent exchange in pharmaceutical manufacturing. J Membr Sci. 2003; 211(2):251-61. [DOI:10.1016/S0376-7388(02)00423-4]
[17] Dehkordi AM. Application of a novel-opposed-jets contacting device in liquid-liquid extraction. Chem Eng Process. 2002; 41(3):251-8. [DOI:10.1016/S0255-2701(01)00141-6]
[18] Kasper JC, Friess W. The freezing step in lyophilization: Physicochemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals. Eur J Pharm Biopharm. 2011; 78(2):248-63. [DOI:10.1016/j.ejpb.2011.03.010] [PMID]
[19] Jameel F, Hershenson S. Formulation and process development strategies for manufacturing biopharmaceuticals. Hoboken: John Wiley & Sons; 2010. [DOI:10.1002/9780470595886]
[20] Subramanian G. Biopharmaceutical production technology. Hoboken: John Wiley & Sons; 2012. [DOI:10.1002/9783527653096]
[21] Wilson FR, Pan W, Schumsky DA. Recalculation of the critical values for Lawshe’s content validity ratio. Meas Eval Couns Dev. 2012; 45(3):197-210. [DOI:10.1177/0748175612440286]
[22] Fong PSW, Choi SKY. Final contractor selection using the analytical hierarchy process. Constr Manage Econ. 2000; 18(5):547-57.[DOI:10.1080/014461900407356]
| Files | ||
| Issue | Vol 7 No 3/4 (2021) | |
| Section | Original Article(s) | |
| Keywords | ||
| Readiness Assessment Biopharmaceutical of Iran Manufacturing Readiness Levels Technology Components E.coli Based Recombinants | ||
| Rights and permissions | |
|
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
How to Cite
1.
Faramarzi M, Noori J, Kebriaeezadeh A, Seyedifar M. Proposing a Local “Technology Readiness Assessment” Model for Biopharmaceutical Industries of Iran. JPPM. 2021;7(3/4):70-81.
