PharmTech Weekly Roundup—Oct. 8, 2026: CPHI Highlights

PharmTech covered one of the industry’s biggest events this week, as CPHI Milan was in full force with experts arguing that formulation, scale-up, quality, and supply can no longer be handled by one department, or one site, at a time. Discussions of how much nitrite is actually safe and whether artificial intelligence (AI) tools and nonclinical models have earned a place in good manufacturing practice (GMP) were featured on PharmTech.com this week.

In the News….

In news this week, the FDA approved Novartis’s oral BTK inhibitor remibrutinib as the first therapy for symptomatic dermographism. The label expansion came from a single multi-cohort phase 3 trial, with each new indication potentially putting pressure on 1 oral solid dose supply chain.

Hovione announced it will commission the world’s first ConsiGma CDC Flex continuous tableting line at its East Windsor, NJ site. The line links spray-dried amorphous solid dispersions to commercial tablets under one quality system and is designed to eliminate traditional scale-up.

In Conference News…

At CPHI Milan, Informa Markets named the winners of the 2026 CPHI Pharma Awards, with honorees including Anemocyte’s enzymatic messenger RNA manufacturing, Evonik’s self-driving labs, and SeraNovo’s NanoGlass platform for challenging oral drugs.

Thermo Fisher Scientific unveiled its OSD Express and Steriles Express offerings at CPHI Milan, along with expanded tableting, sterile fill-finish, and packaging capacity aimed at reducing handoffs across development.

Capsugel’s Bram Baert and Sandrine Picco spoke with PharmTech ahead of the event about their presentation on nitrosamines. They stated that chasing zero nitrite in excipients is often impractical and costly and urged manufacturers instead to set scientifically justified, risk-based limits and stay consistently below them.

Baert and Picco also stressed that nitrosamine risk must be assessed product by product. Nitrosation can occur even when no nitrite is detected, and acceptable levels depend on how raw materials, formulation, process, and packaging interact.

In a pre-show interview, Ron Scarboro, CEO of Azurity Pharmaceuticals, argued that reformulating a drug to remove patient barriers only works if efficacy is preserved, and that someone has to own the product’s entire pathway, from unmet need through approval, supply, and use.

Scarboro also said that packaging and delivery decisions should reflect real-world storage and care conditions. He urged quality and supply teams to track complaints, administration issues, and market availability as measures of success, not just approvals.

Ahead of his presentation at CPHI Milan, Lonza’s Jason Bertola told PharmTech that demand for commercial spray drying is rising because more molecules are poorly soluble. He warned that the biggest misconception is that the process scales linearly.

In the Latest Video Series…

AI Pulse Check this week featured Florin Muraru, Gourav Pandey, and Richard Jaenisch, who warn that shadow AI and vendor data retention put GMP records and trade secrets at risk. Muraru’s minimum policy is to allow only enterprise accounts with zero data retention written into the contract.

The panel also cautioned that as publishers build API access for AI tools, evidence outside those pipelines may quietly stop being cited. Pandey warned of availability bias at scale and expects regulatory citations to need more human verification.

In this week’s Manufacturing Intelligence episode, Richard Jaenisch explained why organoids, organ-on-a-chip systems, and other new approach methodologies may be shortening development faster than AI. Even with the FDA’s new nonclinical testing rule, he expects it to take a year or 2 for these models to earn the trust that animal models hold.

From this week’s content, it appears that pharma’s next gains will come less from any single breakthrough than from connecting the whole pathway and proving every link in it can be trusted. For the full stories, visit PharmTech.com.