Biopharmaceutical companies and health authorities continuously exchange information to provide safe and effective therapeutics. The interactions between the two require transparency and extensive documentation exchange concerning the processes which extend from the development through the manufacturing phase. The current processes rely on paper documentation, notebooks, and point-to-point electronic data interchange (EDI) for the storage of data. Thereby, generating challenges of data integrity within the internal siloed structures and the traceability of the medicinal products in the pursuit to avoid counterfeiting. With Industry 4.0 and blockchain, the authors envisioned a reinvented workflow that helps to 1) manage data integrity with decentralized trust and 2) improve the track and trace capabilities. Hence, biopharmaceutical companies can manage data in a more trustable manner while maintaining security and privacy, further enabling the external ecosystem with track and trace to ensure complete transparency until the therapeutics reach patients.
TopOrganization Background
Since the 18th century, industrial revolutions transformed the production processes from one leaning around craftsmanship to an economy of industrialized machines and processes. Leading to an exponential rise in Gross Domestic Product (GDP), each of the industrial revolutions (1st Mechanical, 2nd Electrical, 3rd Electronical and 4th Cyber-Physical) revolutionized the technological, socio-economical, and cultural levels of societies. Overall, these revolutions provided increased affordability and accessibility of products, along with an enhanced quality of life. Although each industrial revolution also entailed negative and untended environmental and social consequences, they have improved work through innovations, reducing the demand for physical and repetitive labor activities, as the latter can be executed more efficiently by machines. This has led to the rise of knowledge-intensive labourers, which encouraged the migration of people to industrialized zones (Rafferty, 2018). Nowadays, society is witnessing the fourth industrial revolution, which is characterized by the integration and synergies stemming from a wide range of technologies, such as Artificial Intelligence, the Internet of Things, Big Data Analytics, Distributed Ledger Technologies, Robotics, Augmented, Virtual and Mixed Reality, Additive and Smart Manufacturing, Quantum Computing, the Cloud and Edge Computing. These technologies are empowering important developments in manufacturing industries as a lever for productivity, improving quality processes, expanding product portfolio, understanding customer behaviour, enhancing costs effectiveness, and reducing time to market.
The fourth industrial revolution impacts all industries, and the biopharmaceutical industry is not an exception. Digital emerging technologies are affecting the value chain of the biopharmaceutical industry, from Research & Development to the Commercialization stage. However, the biopharmaceutical industry ranks lowest for the use and adoption of digital technologies in comparison to other industries such as retail, finance, media and insurance (Gopal, Suter-Crazzolara, Toldo, & Eberhardt, 2019), due to a challenging regulatory framework (Cauchon, Oghamian, Hassanpour, & Abernathy, 2019).
The biopharmaceutical industry is a high asset and knowledge-intensive industry that deals with the discovery, development, manufacturing, and distribution of medications towards specific health conditions to provide treatments for underlying disease conditions of patients and improve their quality of life. It has two major categories “small molecules” and “biologics or biopharmaceuticals”. Small molecules are produced by chemical synthesis and have a well-defined chemical structure. Instead, biopharmaceuticals are produced from biological sources and consists of a complex and heterogeneous structure (Declerck, 2012). These differences are responsible for a wide gap in the production costs between small molecules and biopharmaceuticals (Makurvet, 2021). Furthermore, the production of biopharmaceutical drugs has a more stringent regulatory pathway in comparison to small molecules due to their complexities, and this impacts the drug development process and the time to market. Indeed, the annual Food and Drug Administration (FDA) approvals for biopharmaceutical products are less than the small molecules (Torre & Albericio, 2021). Moreover, a decline in the productivity of biopharmaceutical research and development led to increased costs within the past few decades (Farid, Baron, Stamatis, Nie, & Coffman, 2020; Scannell, Blanckley, Boldon, & Warrington, 2012). At the same time, the development and manufacturing of therapeutic drugs necessitate sophisticated instrumentation, human capital, scientific knowledge, and stringent regulatory adherence to bring innovative healthcare products to the market to satisfy patient’s needs. Overall, the drug development process takes on an average of 12 years (Van Norman, 2016) and involves costs up to US$2B (Mullard, 2014). In 2019, the Food and Drug Administration approved 48 novel drugs (FDA, 2020b) while pharmaceutical companies worldwide had more than 16 thousand drugs in their Research and Development pipelines (Pharma R&D Annual Review, 2020).