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Business Context-Based Approach for Managing the Digitalization of Biopharmaceutical Supply Chain Operational Requirements
Published
Author(s)
Elena Jelisic, Milos Drobnjakovic, Boonserm Kulvatunyou, Nenad Ivezic, Hakju Oh
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 sup-ply chain networking is used as a specific case study. The investigation results show that, with identified improvements, the approach has the potential to man-age supply chain requirements effectively.
Proceedings Title
Advances in Production Management Systems. Production Management Systems for Responsible Manufacturing, Service, and Logistics Futures
Jelisic, E.
, Drobnjakovic, M.
, Kulvatunyou, B.
, Ivezic, N.
and Oh, H.
(2023),
Business Context-Based Approach for Managing the Digitalization of Biopharmaceutical Supply Chain Operational Requirements, Advances in Production Management Systems. Production Management Systems for Responsible Manufacturing, Service, and Logistics Futures, Trondheim, NO, [online], https://doi.org/10.1007/978-3-031-43662-8_33, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=936885
(Accessed October 7, 2025)