Day 1 at CPHI Milan focused on whether available manufacturing capacity was the right fit. Today, the emphasis shifted from capacity to evidence and what sponsors can verify before committing to a manufacturing partner.

Operating facilities, successful technology transfers, regulatory history and repeatable performance offer a clearer test than capability claims alone, particularly as programmes move towards commercial supply.

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

On the Radar

• Operating capacity is easier to assess: sponsors have more evidence to work with than they do from plans alone.
• Specialist capability needs evidence: transfers, validated methods and commercial experience matter more than capability claims.
• AI needs proof at scale: early gains have to be repeatable, validated and commercially useful.

Operating capacity gives sponsors more to assess

Capacity announcements can shape long-term sourcing decisions, but facilities that are operating or GMP-released give sponsors more to assess before committing a programme.

Aragen Life Sciences said this week that operations have begun at OneHP, its new high-potency development and manufacturing platform in Hyderabad. The facility brings discovery, process development and cGMP manufacturing together for highly potent molecules, including cytotoxic oncology payloads.

WuXi XDC has reached a different milestone in Singapore. Its first overseas manufacturing site has achieved GMP release for antibody-intermediate and conjugated drug-substance production as well as sterile drug-product manufacturing.

The distinction is not that planned capacity has little value. It is that operating and GMP-released facilities reduce some of the uncertainty around whether capacity will be available, qualified and ready when a programme needs it.

Readiness is also a matter of degree: installed equipment, GMP-released capacity and capacity already in use for client programmes provide very different levels of certainty to a sponsor.

Sponsors still need to test technical fit, technology transfer and execution. But there is a material difference between assessing capacity on a development plan and assessing a facility that can already be diligenced.

Specialist capability needs evidence

Specialist manufacturing is difficult to judge from an equipment list or capability statement alone.

Piramal Pharma Solutions offers one measure of established experience. Its Grangemouth site completed its 1,500th ADC batch this year, with the milestone batch representing a commercial oncology product. That provides evidence of manufacturing experience extending beyond development and clinical supply.

The same benchmark is harder to apply in newer modalities, where relatively few suppliers have taken comparable products all the way to market.

Lindsay Davies, CEO of Qvance, explained to Visiongain that previous experience with a similar product remains an advantage, but cannot always be the deciding factor in areas such as cell and gene therapy.

“Of course, experience in bringing a product of the same nature to market previously is a clear advantage, but very few have this track record when looking at some more bespoke products such as cell and gene therapies.”

In those cases, she said the relationship between developer and manufacturer becomes particularly important:

“An understanding of the product and a willingness to work with the developer in readying that product for commercial scale and potentially even global distribution is essential. Such a critical supplier constitutes a partnership, with the product’s success dependent on that manufacturer.”

Quality control and analytics provide another test of whether that capability is ready to scale. Davies highlighted product-specific methods and potency assays in particular:

“Where quality control and analytics come in to this decision is an understanding of what QC is needed, how to validate methods relevant to you and in most cases, the clear differential here will come with the potency assay or assays. Reproducibility and robustness across manufacturing runs, especially with scaling is the true test of this understanding and the critical quality attributes of the product.”

The takeaway is that commercial history remains useful evidence, but it cannot always be the benchmark in emerging therapies. Relevant experience, validated analytical methods and evidence that manufacturing remains robust as a product scales can provide a more meaningful test of readiness.

Digital manufacturing faces the validation test

AI remains prominent at CPHI, but today’s Manufacturing 5.0 discussions focused less on the technology itself and more on what it can deliver inside pharmaceutical operations.

Thermo Fisher Scientific’s Anil Kane examined applications across technology transfer, formulation modelling, deviation investigations, manufacturing performance and automated visual inspection.

Ahead of CPHI, Kane cited one practical example: adding deep learning to an existing visual-inspection system reduced false rejection rates by 85%, cutting manual inspection and potentially shortening the inspection cycle by two weeks.

Results like that provide a clearer test of value than the sophistication of the technology. The harder challenge is taking an improvement into routine GMP use, where data integrity, validation, integration with existing systems and quality oversight all have to hold up.

In a GMP environment, performance is only part of the test. Manufacturers also need clear human accountability and traceability around how data and AI-assisted decisions are handled.

A successful pilot is useful evidence, but the stronger proof is a result that can be validated, reproduced and sustained in a regulated production environment.

Visiongain Insight

As more specialist manufacturing capacity comes online, the harder issue may become execution risk rather than access to capacity itself.

Sponsors can distinguish between suppliers offering similar technical capabilities by looking at what has already been demonstrated: successful technology transfers, validated analytical methods, regulatory experience and reliable performance as programmes scale.

That changes the value of manufacturing capacity. CDMOs able to show that complex programmes can be transferred, qualified and run reliably should have a stronger position than competitors relying mainly on planned capacity or capability claims. Investors and acquirers assessing manufacturing assets face a similar test: installed capacity matters, but evidence that customers can use it successfully matters more.

Visiongain Market Watch is reporting from CPHI Milan 2026. Follow us tomorrow for our final briefing from the show.

From Visiongain

Visiongain’s healthcare, pharma and biotech research helps organisations assess where manufacturing demand is growing, which capabilities are becoming more valuable and how outsourcing, technology and supply-chain requirements are changing across the pharmaceutical value chain.

Related research:

• Peptide Contract Manufacturing Market Report 2026-2036
• mRNA Contract Manufacturing Market Report 2026-2036
• Pharmaceutical Contract Manufacturing Market Report 2026–2036
• Protein Contract Manufacturing Market Report 2026-2036
• Antibody Drug Conjugates Contract Manufacturing Market Report 2026-2036
• Vaccine Contract Manufacturing Market Report 2026-2036

Press & Media Enquiries

For commentary, data requests or interview enquiries, please contact: press@visiongain.com