Contents


compliance. Lorraine Mullaney explores the difference between sterile and non-sterile manufacturing according to the MHRA, speaking to experts along the way.


13 Drying processes for oncological products LAST Technology


15 Making review by exception the rule Aizon


Drug delivery In this issue 10


8 News in numbers The vital statistics defining the pharma industry.


Manufacturing


10 Inside the clean zone Sterile manufacturing in pharmaceuticals ensures products such as injectables and implants are


produced in microorganism-free environments using stringent controls and sterilisation. In contrast, non- sterile manufacturing applies to products like tablets and syrups, focusing on meeting strict microbial limits without requiring sterility. Both processes are essential for ensuring product safety and regulatory


16 AI-driven delivery Artificial intelligence (AI) has emerged as a transformative force in healthcare, with applications spanning diagnostics to drug development. Now, AI/ML models are revolutionising the design of delivery systems, from improving permeability to creating more effective drug carriers. Monica Karpinski delves into the rapidly evolving field of AI-driven drug delivery systems to explore the implications of these advances.


21 Shaping the future of home drug delivery LTS


23 Leveraging the ‘D’ in CDMO to enhance innovation Phillips Medisize


25 Bringing clarity to ophthalmics Terumo


26 Solving the EDDO guidance puzzle


16 World Pharmaceutical Frontiers / www.worldpharmaceuticals.net


A long-awaited draft guidance was released by the FDA in June 2024 that establishes and defines new terminology and seeks to clarify expectations from the agency related to Essential Drug Delivery Output (EDDO) requirements. Abi Millar talks to lawyers Bonnie Odom and Megan Robertson, from Epstein Becker & Green, about what the EDDO draft guidance entails and how industry has been responding.


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