Artificial Intelligence (AI) is changing how biotech and pharmaceutical companies operate. Increased competition and an enhanced regulatory landscape are forcing drug manufacturers to eliminate waste, create efficiencies and squeeze every last bit of productivity out of existing processes. The benefits can be enormous. A three
percent increase in usable yield could increase revenue by millions of dollars. Pharma organizations that take advantage of AI/ML in GxP environments get better visibility into their manufacturing operations and can thereby optimize yields and predict anomalies thereby providing more to the market. We’ll explore where the industry is in its adoption of AI, what the challenges are in implementation that keep the pharma industry behind other industries, and explore case studies of those intrepid organizations who have worked through the challenges to implement and reap the benefits.
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
FDA opens applications for its Expedited IND Pilot, pairing sponsors with qualified research institutions to test rolling CMC review ahead of first-in-human trials.
2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.