Falc Borchard, VP of sales & application at PIA Automation North America discusses how with increasing regulatory expectations and uncertain global supply chains, pharmaceutical manufacturers are rethinking how they design and scale their operations.
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As an event for pharmaceutical and biotechnology manufacturing, INTERPHEX 2026 in New York brings together industry players to address these dynamics and to better connect development, commercialisation and industrialisation.
Conversations onsite highlighted that automation is no longer a downstream consideration, but a central element of manufacturing strategy. In particular, there is a growing focus on scalable concepts that support the transition from early development and prototyping to commercial output, while ensuring compliance with regulatory requirements such as Good Manufacturing Practice (GMP) and enabling efficient, locally anchored execution.
Automation across the full lifecycle
A common theme at INTERPHEX 2026 was the importance of considering automation throughout the full product lifecycle. Production needs shift dramatically from prototyping and small batch sizes through ramp-up phases to serial and high-volume production. Systems that perform well at one stage often struggle at another, particularly when processes change due to scaling, such as when transitioning from manual operations to fully automated production environments. In regulated settings, these transitions can also increase validation effort and introduce additional complexity.
Rather than relying on production concepts that are developed solely for high-volume manufacturing after evaluation and approval phases, the focus is on reusable solutions that can be adapted to new products, batch sizes or processes. Modular designs provide the necessary stability while enabling short ramp-up or adjustment times as production requirements evolve.
By structuring developments into defined automation phases, companies can scale capacity incrementally. They can also reconfigure workflows for new product designs or respond more efficiently to changing regulatory requirements. This approach supports a more controlled and predictable transition from development to full-scale production.
Hybrid solutions for controlled scaling
Hybrid automation concepts are increasingly being used to combine manual and automated processes within a controlled environment. Such approaches were also showcased at INTERPHEX, highlighting flexible production setups that balance process stability, compliance and scalability.
Many pharmaceutical and medical devices, such as autoinjectors, insulin pens and small diagnostic devices, require precise assembly and strict quality control, but may start with lower production volumes. Hybrid systems address this challenge by maintaining product quality and process control during early production phases while keeping the option to scale efficiently as demand increases.
Digital tools driving predictable performance
Another area where companies are realising significant benefits is the use of advanced digital technologies. Digital twinning and virtual commissioning enable early machine validation, reduce project risks and shorten time-to-market.
By simulating production equipment in advance, engineering effort can be reduced, the need for physical testing minimised and the risk of costly delays avoided. In regulated environments, these tools also support documentation and traceability by creating a consistent data basis from early design stages onwards and thereby facilitating compliance with GMP requirements.
Looking ahead
The discussions in New York highlighted a broader shift. Automation is no longer just a tool to improve throughput or reduce costs. It has become a strategic enabler that helps manufacturers scale production, ensure compliance and respond to changing market conditions. Companies that leverage modular design, hybrid production approaches and digital validation tools are better positioned to adapt and scale efficiently while maintaining regulatory compliance and operational resilience. At the same time, there is a growing emphasis on combining global expertise with strong local execution to ensure proximity to customers and faster implementation.
This means that production systems need to be designed with future requirements in mind from day one. Investing in flexible automation solutions upfront pays off when new products are introduced, production volumes increase or regulatory demands evolve. Events like INTERPHEX 2026 highlight that the ability to scale production in a controlled, compliant and flexible way is becoming a key success factor in pharmaceutical and medical manufacturing.