Medicinal product development and manufacturing is a heavily regulated industry, conservative in applying new methods and technologies without understanding and oversight. Yet, the primary mission of regulations is to “ensure that all medicinal products are assessed by a competent authority to ensure compliance with contemporary requirements of safety, quality, and efficacy” [1].
To provide considerations about the technology and gain feedback from stakeholders, in 2023, both the US Food & Drug Administration (FDA) and the European Medicines Agency (EMA) have published reflection papers on the use of AI. Both agencies are leading market authorizations, and their regulatory framework (Title 21 of the Code of Federal Regulations and the Eudralex, respectively) is pivotal in deciding the works of the life science industry to stay in compliance.
FDA’s reflection paper [2] focuses on drug manufacturing and identifies several fields in AI that may have an impact. Of note is the application of AI in “various manufacturing operations such monitoring and maintaining equipment, identifying areas for continuous improvement, scheduling and supply chain logistics, and characterizing raw materials.” It states, “Applicants will need to understand the applications of AI in manufacturing operations subject to regulatory oversight.” EMA’s reflection paper [3] echoes the sentiment, adding that emerging AI technology must still conform to existing regulations governing EU principles on data protection and medicines.
While both regulatory bodies cite a need for a legal framework and thorough understanding of AI technology before usage, both acknowledge the benefits the technology could bring to all phases of the medicinal product lifecycle. Overcoming these challenges can be daunting, but the suitable applications could vastly improve life science companies’ product and process life cycle.
To tackle these challenges, understanding regulatory requirements, applying them practically, and creating a robust process must be combined with embracing emerging technologies. Most companies are busy keeping their operations going, with little time to study the changes’ impact and develop the expertise.
Knightec has an ongoing investment in knowledge of AI technology and existing and experienced knowledge within the life science industry. Working with prominent life science companies such as AstraZeneca and Cytiva, consultants from Knightec have an intimate understanding of every phase in the manufacturing of medicinal products. Joined with expertise within AI technology, Knightec is poised to interpret the regulatory bodies’ requirements and translate them into practical solutions.
AI applications must never be black box solutions: Capable of outstanding results but with little understanding of its model and calculations. Medicinal product manufacturing necessitates understanding the process and setting up and testing scenarios to ensure that users will never be endangered, even during the worst-case scenario. Knightec is ready to provide expertise to unlock this proverbial black box and allow further efficacy and quality assurance of medicinal product development and manufacturing for the customers and the users.
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Hung Nguyen, Senior Consultant, Validation and Qualification at Knightec AB, wrote this reflection. If you need similar expertise as mentioned in the article, contact our validation stars, Jenny Tjernberg, Lina Grudd, and Sofia Zakrisson, or email validation.management@knightec.se.
References
[1] European Commission. (2010). “Eudralex The Rules Governing Medicinal Products in the European Union – EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use – Introduction” European Commission. https://health.ec.europa.eu/system/files/2016-11/2011_intro_en_0.pdf
[2] Center for Drug Evaluation and Research. (2023) “Artificial Intelligence in Drug Manufacturing”. FDA. https://www.fda.gov/media/165743/download
[3] European Medicines Agency. (2023). “Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle.” European Medicines Agency. https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf