Abstract
The COVID-19 pandemic has brought to attention several supply chain challenges in the globalized biopharmaceutical industry. Demand fluctuations and the ability to effectively repurpose manufacturing facilities, and to dynamically adapt scheduling and capacity to respond to those fluctuations are among the important challenges. The biopharmaceutical industry is highly segmented by geography and competency. Companies often must cooperate with other companies dispersed across the globe. While the manufacturing of final products is concentrated in a few western locations, raw materials may come from other parts of the world and the final products have to be distributed globally. Such a diverse environment is further complicated by stringent regulatory requirements and the lack of standardization for many operational raw materials and customization of product recipes. Therefore, it is crucial to have an effective way to document and use the requirements of different supply chain actors. Still, the requirements are usually written in paper form where one actor specifies a set of rules that other actors must follow to communicate specific information effectively. Digitalization, while promising to address this issue, is a stumbling block because of the complexity of the biopharmaceutical industry. Motivated by this challenge, this paper critically evaluates the novel Business Context-based approach for effective (digitalization) management of supply chain (operational) requirements. Biopharmaceutical supply chain networking is used as a specific case study. The investigation results show that, with identified improvements, the approach has the potential to manage supply chain requirements effectively.
Notes
- 1.
The proposed approach assumes a collection of standard components exists.
References
2022, Biopharmaceutical Market, Analysis Report and Region Forecast 2022 - 2030
Yaroson, E.V., Breen, L., Hou, J., Sowter, J.: Resilience Strategies and the Pharmaceutical Supply Chain: The Role of Agility in Mitigating Drug Shortages. In: Barbosa-Povoa, A.P., Jenzer, H., de Miranda, J.L. (eds.) Pharmaceutical Supply Chains-Medicines Shortages, pp. 249–256. Springer (2019)
Tukamuhabwa, B.R., Stevenson, M., Busby, J., Zorzini, M.: Supply chain resilience: definition, review and theoretical foundations for further study. Int. J. Prod. Res. 53(18), 5592–5623 (2015)
Pujawan, I.N., Bah, A.U.: Supply chains under COVID-19 disruptions: literature review and research agenda. Supply Chain Forum 23(1), 81–95 (2022)
Erickson, J., et al.: End-to-end collaboration to transform biopharmaceutical development and manufacturing. Biotechnol. Bioeng. 118(9), 3302–3312 (2021)
Reinhardt, I.C., Oliveira, D.J.C., Ring, D.D.T.: Current perspectives on the development of industry 4.0 in the pharmaceutical sector. J. Ind. Inf. Integr. 18, 100131 (2019)
Figura, M.: Express Pack: Real-Time Release of Raw Materials for the Biopharmaceutical Industry. https://oagiscore.atlassian.net/wiki/spaces/EXPKS/pages/4564287489/Express+Pack+Real-Time+Release+of+Raw+Materials+for+the+Biopharmaceutical+Industry. Accessed: 07 Mar 2023
Score Open-Source Project https://oagiscore.org/. Accessed 29 Mar 2023
Kulvatunyou, B. (Serm), Oh, H., Ivezic, N., Nieman, S.T.: Standards-based semantic integration of manufacturing information: past, present, and future. J. Manuf. Syst. 52, 184–197 (2018)
National Institute of Standards and Technology https://www.nist.gov/. Accessed 23 Jan 2023
“Open Application Group Inc.” https://oagi.org/. Accessed: 23-Jan-2023
“Biopharmaceuticals Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028),” Mordor Intell. https://www.mordorintelligence.com/industry-reports/global-biopharmaceuticals-market-industry#:~:text=The biopharmaceuticals market is estimated,impact on the biopharmaceutical industry. Accessed: 29 Mar 2023
Boehlje, M.: Structural changes in the agricultural industries: how do we measure, analyze and understand them? Am. J. Agric. Econ. 81(5), 1028–1041 (1999)
Zamora, E.A.: Value chain analysis: a brief review. Asian J. Innov. Policy 5(2), 116–128 (2016)
Hernández, V., Pedersen, T.: Global value chain configuration: a review and research agenda. BRQ Bus. Res. Q. 20(2), 137–150 (2017)
Louis, B., Ruslan, R.: Global Value Chains and Smart Specialisation Strategy . Thematic Work on the Understanding of Global Value Chains and Their Analysis within the Context of Smart Specialisation . Global Value Chains and Smart Specialisation Strategy Thematic Work on The (2015)
Kim, Y.C., Atukeren, E., Lee, Y.: A new digital value chain model with PLC in biopharmaceutical industry: the implication for open innovation. J. Open Innov. Technol. Mark. Complex. 8(2), 63 (2022)
Sim, C., Zhang, H., Chang, M.L.: “Improving end-to-end traceability and pharma supply chain resilience using blockchain”, blockchain healthc. Today 5, 1–10 (2022)
2022, “Tools of Tomorrow,” CELL GENE Ther. INSIGHTS, 8(11)
Crawford, M.: Blockchain: Will It Transform the Pharmaceutical Supply Chain?,” GMP Publ (2018)
Elder, D.P., Kuentz, M., Holm, R.: Pharmaceutical excipients - quality, regulatory and biopharmaceutical considerations. Eur. J. Pharm. Sci. 87, 88–99 (2016)
Pan, L.B.: Implementation Roadmap and Real Options Analysis for Biopharmaceutical Technology Introduction in Partial Fulfillment of the Requirements for the Degrees of Master of Business Administration and Master of Science in Chemical Engineering in Conjunction Wit (2013)
Lamberti, M.J., et al.: An examination of eclinical technology usage and CDISC standards adoption. Ther. Innov. Regul. Sci. 49(6), 869–876 (2015)
Upton, J.: Setting Sights on the Smart Supply Chain. Pharm. Exec
Faridi, M.R., Malik, A.: Digital transformation in supply chain, challenges and opportunities in smes: a case study of al-rumman pharma. Emerald Emerg. Mark. Case Stud. 10(1), 1–16 (2020)
Grossman, M., Bates, S.: Knowledge capture within the biopharmaceutical clinical trials environment. Vine 38(1), 118–132 (2008)
USP-NF. https://www.uspnf.com/. Accessed: 29 Mar 2023
European Pharmacopoeia. https://pheur.edqm.eu/home. Accessed: 29 Mar 2023
Japanese Pharmacopoeia 18th Edition. https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/0029.html. Accessed: 29-Mar-2023
British Pharmacopoeia. https://www.pharmacopoeia.com/. Accessed 29 Mar 2023
2020, Chinese Pharmacopoeia 2020 Edition: Key Points, Access Extra https://www.accestra.com/chinese-pharmacopoeia-2020-edition-key-points/. Accessed 10 Apr 2023
Bucerius, M., 2020, “Riding China’s Regulatory Rapids,” Med. Mak. [Online]. Available: https://themedicinemaker.com/business-regulation/riding-chinas-regulatory-rapids. Accessed 29-Mar-2023
Albanese, J.A., Wiggins, M.J.: A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials. BioPharm Int (2020)
Wiggins, J.M., Albanese, J.A.: Pharmacopoeia Compliance: Putting It All Together; What Is on the Horizon.
2022, Thirteenth International Meeting of World Pharmacopoeias https://www.who.int/news-room/events/detail/2022/09/27/default-calendar/thirteenth-international-meeting-of-world-pharmacopoeias. Accessed 30 Mar 2023
Schniepp, S. J.: ALCOA+ and Data Integrity, Pharm. Technol. p. 77
Alosert, H., et al.: Data integrity within the biopharmaceutical sector in the era of industry 4.0. Biotechnol. J. 17(6), 1–8 (2022)
Markarian, J.: Tracking Raw Materials in Biopharma Manufacturing. Pharm. Technol., p. 54 (2019)
Pal, A., Kumar Rath, H., Shailendra, S., Bhattacharyya, A.: IoT Standardization: The Road Ahead, Internet of Things - Technology, Applications and Standardization, J. Sen, ed., BoD – Books on Demand, pp. 53–74 (2018)
Jain, T., Pandey, B.: Knowledge Management Implementation. BioPharm Int (2012)
2009, Core Components Technical Specification CCTS, Version 3.0., p. 162 https://unece.org/DAM/cefact/codesfortrade/CCTS/CCTS-Version3.pdf. Accessed 10 Mar 2021
Novakovic, D.: Business Context Aware Core Components Modeling, Vienna University of Technology (2014)
Ivezic, N., Jelisic, E., Jankovic, M., Kulvatunyou, B., Kehagias, D., and Marjanovic, Z.: Advancing Data Exchange Standards for Interoperable Enterprise Networks (2022)
Jelisic, E., Ivezic, N., Kulvatunyou, B., Milosevic, P., Babarogic, S., Marjanovic, Z.: A novel business context-based approach for improved standards-based systems integration—a feasibility study. J. Ind. Inf. Integr., 30(June) (2022)
2011, The Rules Governing Medicinal Products in the European Union
2021, What Changes When a Drug Candidate Moves from the Research Stage to GMP Production – and Why?. Biovian https://biovian.com/news/the-whys-and-the-whats-of-gmp-production-of-biopharmaceuticals/. Accessed: 07 Apr 2023
Quinn, K.S.: A Holistic Approach to Raw Material Risk Assessments through Industry Collaboration (2019)
2021, Index of World Pharmacopoeias and Pharmacopoeial Authorities
Jelisic, E., Ivezic, N., Kulvatunyou, B., Nieman, S., Marjanovic, Z.: Business Context-Based Quality Measures for Data Exchange Standards Usage Specification, Springer Cham, Valencia
Disclaimer and Acknowledgement
Specific commercial systems and applications identified in this paper are not intended to imply recommendation or endorsement by the National Institute of Standards and Technology, nor is it intended to indicate that they are necessarily the best available for the purpose.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2023 IFIP International Federation for Information Processing
About this paper
Cite this paper
Jelisic, E., Drobnjakovic, M., Kulvatunyou, B., Ivezic, N., Oh, H. (2023). Business Context-Based Approach for Managing the Digitalization of Biopharmaceutical Supply Chain Operational Requirements. In: Alfnes, E., Romsdal, A., Strandhagen, J.O., von Cieminski, G., Romero, D. (eds) Advances in Production Management Systems. Production Management Systems for Responsible Manufacturing, Service, and Logistics Futures. APMS 2023. IFIP Advances in Information and Communication Technology, vol 689. Springer, Cham. https://doi.org/10.1007/978-3-031-43662-8_33
Download citation
DOI: https://doi.org/10.1007/978-3-031-43662-8_33
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-031-43661-1
Online ISBN: 978-3-031-43662-8
eBook Packages: Computer ScienceComputer Science (R0)