CPHI Milan 2026 Day 1: Manufacturing Moves Beyond Capacity

At CPHI Milan, the manufacturing question is no longer simply how much capacity is available, but whether it is the right capacity for the products pharma needs to make.

Three issues ran through today’s programme and company announcements: specialist manufacturing capability, more resilient supply networks and whether AI can deliver measurable improvements on the factory floor.

This is the first of Visiongain’s daily briefings from CPHI Milan 2026.

On the Radar

Specialist capacity is the constraint: available space has limited value without the technical fit and transfer capability to use it.
Backup only works if it is ready: resilience depends on alternative manufacturing capacity being transferable and available before disruption occurs.
AI’s next hurdle is scale: early gains still need to survive system integration, GMP validation and wider deployment.

Specialist capability is reshaping the capacity question

Available manufacturing space matters only if it fits the product, process and stage of development.

That is particularly important in cell and gene therapies and ADCs, where capacity is highly specific. Viral-vector production, cell processing, payload-linker manufacturing and conjugation require different facilities, skills and quality controls. Spare capacity in one part of the process cannot necessarily solve a constraint elsewhere.

Thermo Fisher Scientific is using CPHI Milan to highlight new and expanded sterile drug-product capabilities in Monza and Ferentino in Italy and Plainville in the US, alongside a more defined technology-transfer pathway. Thermo Fisher says the latter can deliver a Phase III GMP batch in as little as 26 weeks.

The strategy links physical capacity with the ability to move programmes into it more efficiently. An available manufacturing slot has limited value if technology transfer, validation or scale-up becomes the bottleneck.

In practice, technology-transfer capability and commercial readiness can matter as much as the open manufacturing slot itself.

Resilience is changing the outsourcing equation

One of today’s manufacturing debates at CPHI went directly to the tension facing pharma companies: do fewer, deeper CDMO relationships improve execution, or create new dependencies?

The attraction of consolidation is clear. Fewer partners can simplify technology transfer, planning and governance, but concentrating critical production with a small number of suppliers can also create single points of failure.

A different approach to resilience comes from Gaelic Laboratories and Athlone Laboratories. Following Gaelic’s acquisition of Athlone last year, the companies have aligned manufacturing processes so customers can source the same beta-lactam antibiotic products from either of their two Irish facilities.

The model does not remove every concentration risk, but it gives customers a second aligned manufacturing option without requiring a separate external supplier. That preparation matters: moving production to a new site can require lengthy validation and regulatory approval, making an unprepared backup difficult to use once disruption has already occurred.

The value of redundancy therefore depends on whether alternative production can actually be activated when it is needed. That puts a price on resilience: sponsors have to decide where the cost of maintaining a viable backup is justified by the risk of disruption.

AI faces the harder test: scaling in GMP manufacturing

CPHI Milan has added a dedicated AI & Tech area this year, with manufacturing applications ranging from digital twins and predictive maintenance to quality systems and process optimisation.

Recordati used its session today to show what happened after an earlier AI pilot delivered a reported 1.5% improvement in yield and a 2% reduction in cost of goods within 90 days. The pilot also exposed a more difficult problem: fragmented data and paper batch records made real-time use difficult.

The company has since digitised 11 master batch records and connected sensor monitoring, SAP picking lists and operator instructions into a common execution layer. The progression illustrates the harder manufacturing challenge: proving an AI use case is one thing; integrating it into routine, regulated production is another.

Reliable data, integration with existing systems and an approach that can withstand GMP scrutiny will determine whether early gains can be reproduced at scale.

The test is moving beyond whether AI can improve an individual process to whether those improvements can be validated, repeated and embedded across real manufacturing operations.

Visiongain Insight

The first day at CPHI Milan suggests that manufacturing partners are being judged against a broader test. Available capacity has to come with the ability to transfer and scale increasingly specialised products, maintain viable alternatives when supply is disrupted and turn digital investment into something that works inside a regulated production environment.

CDMOs that add scale without strengthening specialist capability, resilience and execution may find that size alone carries less weight in partner selection. Sponsors, meanwhile, have more reason to test what a manufacturing partner can deliver under pressure, not simply what it can offer on paper.

Visiongain Market Watch is reporting from CPHI Milan 2026. Follow us for further analysis from the show.

From Visiongain

Visiongain’s healthcare, pharma and biotech reports help organisations assess where clinical development demand is growing, which capabilities are becoming more valuable and how trial models are changing across the pharmaceutical value chain.

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