As pharmaceutical pipelines grow more complex and development timelines compress, packaging has evolved from a downstream operational step into a strategic enabler across the product life cycle.
From oral solid doses requiring late-stage customisation to high-potent and drug-device combination products demanding advanced containment and scalability, today’s packaging decisions directly influence speed to market, regulatory success and patient experience. In this interview, Paul Smallman, Senior Technical Sales Director at PCI Pharma Services, shares his perspective on how packaging is adapting to meet the needs of modern therapies and why integration between clinical and commercial operations is now critical to long-term success.
PMPS: How would you characterise the current state of pharmaceutical packaging?
Paul Smallman (PS): Pharmaceutical packaging is undergoing a fundamental transformation. Historically, packaging was viewed as a downstream, largely tactical activity focused on protection and compliance. Today, it has become a strategic enabler across the product life cycle. As pipelines shift toward patient-centric drug-device combination products, biologics, targeted therapies and high-potency compounds, packaging must deliver far more than containment. It must enable agility, patient usability, global scalability, sustainability and, increasingly, digital traceability. For injectables, packaging is no longer just about containment; it is a critical component of product performance, safety and usability. Primary packaging must ensure drug stability, compatibility with delivery devices and precise dosing, while supporting sterility throughout the supply chain. Human factors considerations are increasingly central, particularly as therapies move to self-administration, demanding ergonomic, intuitive designs that minimise administration errors. Overall, factors such as accelerated development timelines, smaller patient populations and more fragmented global launches are demanding flexible packaging solutions capable of adapting rapidly to scientific, regulatory and commercial realities.
PMPS: Oral solid dose (OSD) products still represent a large portion of the market. What is changing most in this space?
PS: The biggest shift in OSD packaging is the move away from scale-driven efficiency toward agility-driven efficiency. Traditional models relied on long production runs, fixed stock keeping units (SKUs) and predictable demand. That however does not work for today’s precision medicines, orphan indications or regionally staggered launches. Late-stage customisation (LSC) has emerged as a highly effective strategy. By delaying final packaging configuration such as printing, labelling or country-specific artwork until demand and destination are confirmed, companies can significantly reduce waste, inventory risk and working capital exposure. Digital printing technologies enable this flexibility, allowing neutral ‘brite stock’ to be customised late in the process without compromising compliance or speed. From a technical perspective, this also helps address what we often refer to as ‘complexity creep’, where SKU proliferation downstream creates operational bottlenecks. LSC narrows that funnel, improving responsiveness across both clinical and commercial supply.
PMPS: How does this agility translate into clinical development environments?
PS: In clinical programmes, protocols evolve, labelling changes frequently and batch sizes are small. On-demand labelling and flexible packaging configurations are essential. They allow sponsors to respond quickly to protocol amendments, regional regulatory updates or enrolment changes without having to waste large volumes of pre-configured materials. Importantly, when LSC is designed into clinical packaging from the outset, it creates a smoother transition into commercial operations, avoiding requalifying new packaging strategies at scale, saving both time and cost.
PMPS: High-potent and targeted therapies continue to grow. What packaging challenges do these products introduce?
PS: High-potent active pharmaceutical ingredients, particularly in oncology and targeted therapies, place extraordinary demands on packaging environments. Occupational exposure limits are extremely low, often in the nanogram range, which means containment is essential. The challenge is balancing frequent changeovers and small batch sizes with containment integrity, and that is where thoughtful facility and process design become essential. Modern high-potent packaging suites are engineered ecosystems, incorporating negative-pressure environments, high air-change rates, dedicated heating, ventilating and air conditioning systems, and strict personnel and material flows to prevent cross-contamination, while standardised measurement of equipment particulate airborne concentration testing is typically conducted to validate containment performance before commercial operations begin.
PMPS: Injectables and drug-device combination products seem to represent a high level of complexity. How is packaging evolving here?
PS: Packaging for injectables and drug-device combination products is evolving rapidly to meet growing complexity in biologics, high viscosity formulations and patient-centric self-administration dosing. Injectable and drug-device combination products are where packaging truly intersects with engineering, human factors and patient experience. Primary packaging now does more than contain the drug, it must interface seamlessly with delivery devices, maintain sterility and ensure precise drug delivery. From a technical standpoint, this requires precision assembly, functional testing, labelling, packaging, serialisation and often cold-chain management all within a tightly controlled environment. Human factors engineering is increasingly central. Regulators now expect clear evidence that patients can safely and effectively use these products, which means packaging design directly influences regulatory approval and commercial success. With scalability being another key consideration, automation and flexible manufacturing lines are increasingly critical. Assembly and packaging platforms must support early-phase pilot volumes and scale efficiently into high-volume commercial supply without introducing new risk. Modular, device-agnostic technologies are becoming the standard for achieving that flexibility – from small pilot operations processing a few units per minute to fully automated commercial systems running hundreds of units per minute.
PMPS: Sustainability is a major industry focus. How realistic is it to balance sustainability with safety and regulatory expectations?
PS: Balancing sustainability with safety and regulatory requirements requires a pragmatic, science-driven approach. Patient safety and product integrity will remain non-negotiable, particularly for sterile and injectable products. Sustainability is acheivable through incremental, validated changes, such as light-weighting packaging, reducing over-packaging, optimising pack sizes, and using recyclable or responsibly sourced materials without compromising sterility or stability. Advances in material science, downgauged plastics, hybrid materials and digital printing further support environmental goals while maintaining compliance. Early integration of sustainability into development, backed by risk assessments, stability data and regulatory justification ensures changes align with quality by design principles. Ultimately, sustainable packaging can reduce environmental impact.
PMPS: How important is integration between clinical and commercial packaging operations?
PS: Integration between clinical and commercial packaging operations is critically important, particularly as development programmes become more complex and timelines continue to compress. Early alignment ensures that packaging formats, materials, processes and technologies selected for clinical trials can be efficiently scaled and validated for commercial manufacture, avoiding costly redesigns, requalification or regulatory delays later in development. For drug-device combination products, this integration is even more essential. Decisions made during early clinical phases such as device selection, labelling strategy, serialisation approach and cold chain requirements directly influence commercial readiness. When clinical and commercial teams operate in silos, sponsors often encounter bottlenecks at scale-up, including tooling limitations, inconsistent supplier qualification or gaps in regulatory documentation. An integrated approach enables continuity of knowledge, data and quality systems across the product life cycle. It supports smoother technology transfer, more predictable timelines and better capital efficiency, while maintaining compliance across global markets. Ultimately, close integration allows sponsors to move faster and with greater confidence, ensuring that packaging strategies evolve in step with clinical progress and long-term commercial objectives.
PMPS: Finally, how do you see the role of packaging evolving over the next decade?
PS: Over the next decade, packaging will evolve from a largely functional end-stage activity into a strategic enabler across the drug product life cycle. As pipelines continue to shift toward complex biologics, targeted therapies and drug-device combination products, packaging will play a much earlier and more integrated role in development, influencing manufacturability, regulatory strategy, patient usability and supply chain resilience. We will see greater emphasis on packaging systems designed for scalability from early clinical phases through commercialisation, reducing risk and rework as programmes progress. Patient-centric design will also become increasingly important, particularly for self-administered therapies, where packaging must support ease of use, adherence and safety while accommodating more complex devices and delivery formats. Organisations that treat packaging as an innovation platform will gain a significant competitive advantage. Packaging is no longer the last step in drug delivery; it is a critical signal that innovation has successfully reached the patient safely, efficiently and responsibly.