EDUARD CAYÓN
Chief Scientific Officer (CSO) at REPHINE, Barcelona, Spain

Abstract

New waves of innovation in Life Sciences, and a redoubled effort by regulators to maintain patient safety, are placing increased pressure on drug and device manufacturers to assure the consistent standards across manufacturing processes, systems and supply-chain partnerships. After practical supply chain issues in 2022, added to the impact of continued medicinal/device innovation, 2023 will bring new regulatory changes linked to process digitalisation and automation. REPHINE’s Dr. Eduard Cayón discusses the implications.

The Life Sciences industry has never needed a robust manufacturing and supply chain Quality backbone more than it does now. As a result of the pandemic, then further aggravated by the war situation in Europe, the problem of shortages of some medicines persisted in 2022. The continued/repeat closure of China and the difficulties in the supply of raw materials presented a major problem, forcing pharma companies to rethink their reliance on far-flung markets for APIs and other raw materials. To ensure supply security, manufacturers have had to review their sourcing options and, in many cases, opt for alternatives closer to home - despite the associated expense. This activity continues, and with it the need to review the quality performance and compliance records of new suppliers or alternative manufacturing sites in Europe or North America.

Meanwhile, a whole raft of innovation and new medicines is now being focused on macromolecules from biotech processes, or the adaptation of existing medicines through the addition of medical devices and/or app-based digital controls and data exchanges. As the regulatory environment strives to adapt its quality and safety requirem ...