PharmTech Weekly Roundup—September 18, 2026

This week on PharmTech.com, artificial intelligence was analyzed as it is used in formulation labs, risk files, and quality systems, while conference season put quality culture and audit rigor back in the spotlight. Meanwhile, manufacturers kept reshaping where and how they make things, from portfolio divestments to new spray drying capacity.

In Industry News…

In news this week, FDA's new Expedited IND Pilot will review CMC, pharm/tox, and clinical components on a rolling basis before formal submission, with Acting Commissioner Kyle Diamantas framing it as a bid to keep pace with China on early-stage drug development.

Hovione opened a new 31,000-square-foot spray drying facility in New Jersey, which doubles its US capacity for turning poorly soluble compounds into amorphous solid dispersions within the same quality system as its drug substance operations.

Sanofi's divestment of 20 mature medicines and 3 manufacturing plants to Cheplapharm, in exchange for a 26.4% equity stake, reflects a push to simplify the portfolio and free up capital for pipeline investment.

In Conference News…

In conference coverage, after acquiring a San Diego sterile fill-finish site that promptly drew an FDA Form 483, PCI's B. Timothy Bassler told the PDA/FDA Joint Regulatory Conference in Washington, DC, that rigorous shop-floor oversight and clear escalation authority turned a Voluntary Action Indicated outcome into a rebuilt quality system.

Sanofi's Helen Motamen reminded the attendees at the PDA/FDA Joint Regulatory Conference that internal audits are patients' last line of defense, built on independent, continuously qualified auditors and risk-based agendas rather than tenure alone.

Eli Lilly's Karthik Iyer argued that AI in quality systems needs governance before technology, warning that hallucination rates as high as 94% mean any surfaced findings must stay traceable and human reviewed.

Genentech's Lori Dingledine told the PDA/FDA conference that advanced therapy programs succeed or stall on raw material execution, urging early vendor audits and dual sourcing to bridge the gap between research-grade and GMP materials.

And AbbVie's Karyn Campbell walked through 2 audit case studies where incomplete corrective actions resurfaced at later inspections, reinforcing her point that a CAPA is only as strong as the root cause investigation behind it.

In a preview of the upcoming CPHI Milan, Quotient Sciences’ Andrew Parker explained how AI-driven Bayesian optimization is helping formulators converge faster on a target profile, provided manufacturability is planned in from the earliest molecular design stage.

Parker's case for AI-enhanced adaptive dose titration shows how deferring dose-strength decisions until after early human data keeps formulation teams from wasting resources on stage-inappropriate development.

The Experts Say…

In expert commentary this week, Plarent Ymeri of Smarteeva makes the case that continuous, AI-assisted monitoring of complaint and post-market data could finally close the months-long lag between a rising failure signal and a formal risk file review, especially for dual-regulated combination products.

And BioPharm International’s Feliza Mirasol tracks 2026's rapid pivot from IV to subcutaneous biologics, where the FDA's July approval of a subcutaneous isatuximab formulation cut infusion reactions from 25% to 1.5% and is pushing CDMOs to expand fill-finish and device-assembly capacity.

This week's stories show that AI is only as good as the human governance and root-cause discipline built around it. For the full stories, visit PharmTech.com.