Abstract
In the last decade, the adoption of sophisticated modeling, machine learning, and artificial intelligence, combined with process analytical technologies like Raman and NIR, has become commonplace in Johnson & Johnson's manufacturing landscape. This transformation has driven groundbreaking achievements once considered pure science fiction-such as real-time release of oral solid dosage forms, central & automated process control, and remote fault detection that surpasses human capabilities, demonstrating tangible value and opening new horizons for innovation. This presentation will reflect on our manufacturing & supply chain journey, sharing key lessons learned and focusing on next steps. As we relentlessly pursue new cures, these technological innovations form a vital part of a comprehensive system dedicated to ensuring the high-quality, reliable supply of complex medicines. With the advent of Cell and Gene Therapies, which introduce substantial patient-specific variability, existing ML and AI tools are being challenged-reminding us that our ongoing mission remains centered on delivering safe, effective, and affordable medicines to patients worldwide, with confidence in outcomes and supply.