Automation and drug development are a perfect match. The most obvious benefits of automation are increased reliability and improved efficiency, overcoming some of the biggest obstacles in the pharmaceutical industry: inconsistencies and wasteful processes.
The well-known figures on failures in this field are clear evidence of the need for modern technology: 90% of medicines Failure Losses incurred during development can amount to as much as 60% of R&D costs.
Implementing technology that can improve these dire statistics is a business imperative. Industry 4.0 Innovation, an acronym for the application of technologies such as automation, robotics, and machine learning to industrial processes, is driving rapid and redefining change in drug discovery. One of the key benefits of these innovations is their impact on the robustness and quality of drug development information, or data integrity.
This article discusses ways to improve data integrity in the digitalized pharmaceutical sector and the new risks that adopting these technologies may pose.
Benefits of Industry 4.0
Filipa Mascarenhas MeloThe associate professor at Portugal’s Polytechnic University of Guarda said Industry 4.0 innovations offer “unprecedented opportunities” for pharmaceutical companies.
Enhanced traceability is one of the key benefits offered by the transition from analog to digital data. While handwritten lab reports and analytical readouts can be lost, damaged or falsified, automated processes can be orchestrated to record and store each step of the process, making analysis much easier for companies and regulators. Dr. Steven GoldrickThe associate professor of digital bioprocess engineering at University College London called these changes “vital.”
“This evolution reduces concerns about manual processing errors and makes electronic batch records easier to manage, store, retrieve and query,” he added.
Mascarenhas Melo points to systems such as electronic data management systems (EDMS) and laboratory information management systems (LIMS) that allow electronic documents and samples to be tracked within a workflow. A blockchain-based system, which provides a fixed ledger that tracks data entries, can be used to track the entire pharmaceutical supply chain. This increases “transparency, reliability and completeness of data related to the production, distribution and sale of medicines,” Mascarenhas Melo said.
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Industry 4.0 tools also simplify data recovery after system failures, facilitate secure communications and data encryption protocols, and make it easier to implement quality control protocols that ensure data integrity.
As digitalization improves pharmaceutical company workflows, regulators in the sector will need to adapt their own processes to accommodate these new technologies. Mascarenhas Melo recently said: review and Good Automated Manufacturing Practice (GAMP), a set of recommendations for the design of digital systems published by the International Society for Pharmaceutical Engineering (ISPE).
The original GAMP was created in response to the emergence of digital workflows in 1991, but the latest version, the second edition of GAMP 5, released in July 2022, bears little resemblance to its 33-year-old predecessor. “The latest edition of GAMP 5 recognises the non-linear, agile and cyclical nature of modern software development and reflects the industry’s shift towards continuous iteration and innovation,” Mascarenhas-Melo commented.
Regulators must prioritize “agility and responsiveness,” she said. And yet it took ISPE 14 years to release an update to the first edition of GAMP-5, published in 2008. During that time, the digital infrastructure of many companies has fundamentally changed. The rise of cloud software has made it easier to update and expand; AI Tools on site.
Eternal principles guiding regulation
Even in the face of such fundamental change, data integrity practices have proven to be an enduring cornerstone of regulation. The acronym ALCOA stands for Good Data. Attributable, legible, contemporaneous, original and accurate, first Coined word Developed by FDA’s Stan W. Woolen in the early 1990s, ALCOA remains “unique for its effectiveness and broad recognition within the industry” (though now in a revised version that also considers data completeness, consistency, durability, and availability), Goldrick said. By using these agnostic principles as a guide, regulators hope to make their guidance more adaptable in the face of technological change.
“The percentage of violations requiring action has decreased, which may indicate an improvement in pharmaceutical companies’ compliance efforts,” Mascarenhas Melo explains.
While regulators and companies have successfully navigated these changing technologies while ensuring data integrity, Goldrick points out that keeping staff and users on board is a key element that risks being overlooked: “Implementing and maintaining these systems requires significant user training, and the cost and time spent on training is significant,” he says.
Mascarenhas-Melo highlights the new GAMP-5 guidelines, which encourage end users to work extensively with their suppliers and leverage their expertise in maintaining digital systems, while suppliers must adapt to new ongoing support models that involve working closely with end users long after the sale has been completed.
The risks of Industry 4.0
Any fully digitalized process will have security vulnerabilities that suppliers and drug companies need to prepare for, Goldrick said.“Reliance on cloud storage increases the industry’s exposure to cybersecurity threats, including the potential for unauthorized access to sensitive or patient-specific information,” he says.
These risks are already evident. attack The attack on UnitedHealth, the world’s largest healthcare company by revenue, threatened to release patient data and shut down pharmacy operations for several days. strike Attack on pharmaceutical giant Cencora. Ensuring the integrity of sensitive medical data and training those who manage it is the only way to protect against attacks like this.
How to ensure data integrity in an evolving environment
The showdown between the pharmaceutical industry and Industry 4.0 technologies will continue. The question is not whether the technologies will change the industry, but who will be the first to exploit the new situation to their own advantage: industry players, regulators, or cybercriminals.
To make their systems secure and maximize data integrity, pharmaceutical companies will need to invest in both hardware and proper training of staff. While the costs may deter some, Mascarenhas Melo has a warning for companies that are slow to act: “Slow adopters will struggle to catch up as their more digitally advanced peers pull ahead, and could find themselves at a competitive disadvantage.”
About the interviewee:
Dr. Filipa Mascarenhas Melo is an Assistant Professor at the School of Advanced Health Sciences, Polytechnic University of Guarda, Portugal, and an Integration Researcher in the BRIDGES (Biotechnology Research, Innovation and Design for Health Products) program at the same university, and a Collaborative Researcher at the School of Pharmaceutical Technology, University of Coimbra.
Dr Steven Goldrick is a Lecturer and Associate Professor in Digital Bioprocess Engineering in the Department of Biochemical Engineering at University College London. He specialises in the application of mathematical modelling and advanced data analytics to biotechnology processes.
References:
1. van der Graaf PH. Probability of success in drug development. Clinical Pharmacology2022;111(5):983–985. Source: 10.1002/cpt.2568
2. Pedro F, Veiga F, Mascarenhas-Melo F. The impact of GAMP 5, data integrity and QbD on quality assurance in the pharmaceutical industry: how clear is it? Drug Discovery Today2023;28(11):103759. Source: 10.1016/j.drudis.2023.103759
3. Bongiovanni S, Purdue R, Kornienko O, Bernard R. Quality in non-GxP research environments. In Bespalov A, Michel MC, Steckler T (eds). Good Research Practices in Nonclinical Pharmacology and Biomedical Sciences. Springer International Publishing; 2020:1-17. doi: 10.1007/164_2019_274
