How Digitalization Is Transforming Pharmaceutical Manufacturing Processes

Laine Mello, director of Marketing at Ecolab for its bioprocessing business, shares her insights on the digital transformation of the pharmaceutical sector, the shift from batch to continuous processing, and the economic drivers shaping the industry’s future into 2026.

PharmTech: How is AI reshaping the drug discovery and manufacturing landscape?

Mello: We are seeing AI fundamentally change the drug discovery timeline. Researchers are now able to design new molecules in weeks rather than months, which is an incredible shift that helps identify promising candidates with precision that wasn't possible even two years ago. This acceleration has massive implications for how quickly therapies can reach patients. On the manufacturing side, the impact is just as significant. Predictive maintenance tools are now catching equipment issues before they cause batch failures, and real-time analytics are allowing for much faster quality decisions. Digital monitoring is even making continuous processing more viable by removing the uncertainty that previously made manufacturers hesitant to move away from batch production.

What primary hurdles prevent companies from full adoption?

Adoption isn't always straightforward because regulatory frameworks are still catching up. There is an understandable need for transparency in how AI makes critical decisions, especially when patient safety is involved. Many facilities are struggling to integrate cutting-edge digital tools with legacy systems that might be 10-15 years old. We also have to address data governance and cybersecurity; these are not solved problems yet, and they cannot be afterthoughts when you are dealing with sensitive manufacturing data.

What benefits does continuous manufacturing offer over traditional methods?

It’s been a game-changer, we’ve seen facilities cut production cycles by 30%-40% while actually improving consistency. Shifting away from batch processing isn't just about increasing speed, it fundamentally changes how quality control and scale-up work. Once a facility can run continuously, it opens the door to optimizing operations in ways that simply weren’t possible before.

How is the industry responding to increasing margin pressures and the need for better process economics?

The industry is responding to margin pressure by investing heavily in next-gen therapies, such as biologics and advanced modalities that offer clinical benefits that generic competitors cannot easily replicate. This shift creates a demand for sophisticated purification solutions. For example, high-capacity chromatography resins are helping manufacturers maximize yield and recovery. These advanced resins enable intensified processing, which translates directly into cost savings and faster throughput. For biologic manufacturers dealing with complex molecules, these improvements in purification efficiency can be the difference between a commercially viable process and one that struggles economically.

What digital technology and sustainability shifts did you see in 2025?

In 2025, digital technology stopped being a "nice to have". Companies that had been piloting AI or the IoT for years suddenly found themselves racing to implement these tools across R&D and manufacturing to avoid falling behind the competition. At the same time, sustainability moved beyond simple compliance to become a genuine competitive differentiator. Companies are discovering that reducing water and energy consumption isn't just good for the planet, it improves their bottom line and makes their operations more resilient.

What will be the defining priorities for bioprocessing in 2026?

The reduction of the cost of goods will be the defining priority in 2026. Pricing pressures are intensifying, particularly for complex biologics. Manufacturers need to squeeze more productivity out of every single process step. We expect continuous and intensified bioprocessing to move from being innovative to becoming a standard practice, utilizing modular facilities and multi-column chromatography to deliver flexibility without sacrificing efficiency. We are also focused on solving technical challenges like stability and aggregation for high-concentration biologics and mRNA platforms that push the limits of current manufacturing.

How is the relationship between pharmaceutical companies and their suppliers changing?

We are seeing a shift where pharma companies are no longer looking for transactional relationships. Instead, they expect suppliers to act as strategic partners. This involves co-creating solutions, sharing technical expertise, and collaborating on process innovations. Using collaborations and acquisitions to access new technologies quickly is becoming essential for staying agile in a market where competitive advantages can erode very quickly.