Contents Packaging


37 Under the surface From plastics to inks, packaging materials can leach unseen chemicals into sensitive drug products, potentially compromising the medicine’s effectiveness and safety. Natalie Healey peers inside the quiet but high-stakes world of extractables and leachables with expert insight from consulting toxicologist Dr Greg Erexson.


Manufacturing


40 AI now: What QbD and PAT missed While AI is transforming pharmaceutical R&D and manufacturing, legacy frameworks like quality by design (QbD) and process analytical technology (PAT) have fallen short of expectations. Digital life sciences advisor Michael Louie, pharma AI start-up founder Nikolai Makaranka and Grace Cronin of Bristol Myers Squibb talk to Ellie Philpotts about exploring how AI could succeed where others stalled – if data quality, infrastructure and cross-functional collaboration are prioritised from the start.


43 Revolutionising component transfer on the line LDI Protection


45 Ringing the alarm: Unified data for GMP Annex 1 compliance Aizon


46 Prevention of exposure LAST Technology


Clinical Trials Insight


Turn to page 47 for our supplement on the latest regulations and strategies in clinical trials.


Chemicals & raw materials


67 The clean chemistry shift The peptide manufacturing industry is moving towards sustainable practices. But sustainable


6


manufacturing also includes the carbon footprint of the process, which considers waste management, resource efficiency and more. Looking at the process holistically, Monica Karpinski investigates how to reduce its environmental impact, speaking to Alessandra Tolomelli of the University of Bologna and Fernando Albericio of the University of Barcelona along the way.


71 Pioneering sustainable peptide synthesis Bachem


67


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73 End-to-end peptide manufacturing PolyPeptide


75 The immune system’s unwanted response Mimotopes


76 Enhancing bioavailability Colorcon


77 Navigating a greener future Biosynth


78 APIs to the rescue? Oral bioavailability remains one of the biggest challenges in drug development, particularly for small-molecule APIs with poor solubility or permeability. Liam Critchley explores how pharmaceutical companies are using integrated formulation strategies – including amorphous solid dispersions, nanosizing and lipid carriers – alongside advanced data analytics and AI-driven approaches to accelerate discovery, enhance solubility and reduce development timelines for traditionally hard-to- formulate drugs.


Events 81 Conferences and key dates


www.worldpharmaceuticals.net


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