Ensuring Product Quality in Irish Biologic and Biopharmaceutical Logistics through IoT-enabled Cold Chain Monitoring

Abstract

The fourth industrial revolution along with the advancement in digital technologies have revolutionized the realm of biologics and biopharmaceutical logistics. This dissertation embarks on a journey to explore the integration of Internet of things (IoT) enabled technologies in cold chain monitoring within the Irish biologic and biopharmaceutical logistics sector. The study focuses on ensuring the quality and safety of temperature-sensitive biologics and biopharmaceutical products like gene therapies, monoclonal antibodies, vaccines, diagnostic kits and reagents during storage and transportation till it reaches the end customer. The study is relevant especially for a country like Ireland renowned for being one of the leading global hubs in biopharmaceuticals, medical device technology and digital health technology. The biologic and biopharmaceutical logistics industry of Ireland rely heavily on efficient and reliable cold chain monitoring to ensure the quality, safety, and efficacy of temperature sensitive medications, vaccines, and biologics. The ever-increasing demand for vaccines, gene therapies, monoclonal antibodies, and biomedical products like diagnostic reagents and medical laboratory supplies post COVID-19 pandemic has made it important to maintain the optimal storage conditions throughout their transit within the supply chain. Industry 4.0 technologies like the Internet of things (IoT) can be a game changer in the cold chain logistics through its capabilities in offering real-time monitoring of temperature and other environmental factors like humidity, pressure, etc. Through time-monitoring, anomalies in temperature and other environmental factors can be detected immediately and immediate measures can be taken to prevent any adversities, thus ensuring the safety and efficacy of the product. This research further aims to emphasise the understanding of available IoT technologies having the potential to transform the biologic and biopharmaceutical cold chain, thus enhancing product quality and ensuring patient safety.