Quality by Design (QbD) for Biologics: A CDMO's Perspective

Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains how AI is integrated into pharmaceutical development.

PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.

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.

Karthik Iyer, Eli Lilly, details an AI system linking GMP findings, audits, and deviations for cited, inspection-ready regulatory intelligence.

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.