Latest Articles

  • Material-Sparing Strategies for Rapid Development and Scale-Up of Complex Drug Products

    In an industry where complex molecules and first-in-human (FIH) formulations often come with very limited API supply, material-sparing strategies are central to efficient CMC development. read more

  • Status Of AI Regulation On Drug Development

    As AI capabilities scale, the FDA expects sponsors and their outsourcing partners to treat AI like any other regulated, computerized system that can influence safety, effectiveness, or quality–define the role, document credibility, control the lifecycle, and monitor performance. read more

  • Executive Q&A - Early Drug Development

    In this Q&A, we explore early-stage pharmaceutical drug development trends, key scientific and technical challenges, and the role emerging technologies play in enhancing efficiency and quality during early pharmaceutical development. read more

  • Sustaining the Future of Life Science Product Research

    Few people say it outright, but the integrity of stored research and clinical samples underpins all scientific and medical progress. Every breakthrough drug, advanced therapy, or medical device depends on millions of biological, chemical, and physical samples that must be preserved intact across the entire product lifecycle. read more