One of the biggest challenges in injectable delivery today is managing the increasing complexity of drug-device combination products, balancing batch sizes from large commercial volumes to rare/ultra-rare small volumes, while maintaining speed to clinic and speed to market.
The rapid growth of biologics, high-concentration formulations, and patient-centric delivery systems means companies must simultaneously address formulation development, sterile manufacturing, device integration, regulatory requirements, and global supply chain considerations – all while reducing development timelines.
PCI addresses this challenge through an integrated approach that combines device assembly, packaging, analytical services, and sterile fill-finish in one organization. “By bringing these capabilities together, we help clients reduce hand-offs between vendors, mitigate program risk, and streamline the path from clinical development through commercialization,” says Paul Smallman, Senior Director, Global Technical Sales, PCI. “Our teams work closely with customers to evaluate formulations, device selection, assembly processes, human factors considerations, and packaging configurations early in development. This proactive approach helps identify potential issues before they impact timelines or regulatory submissions.”
In parallel, the global sterile manufacturing and packaging network provides the scalability and flexibility needed to support emerging biotech companies and large pharmaceutical organizations as product demand evolves. Sustainability has become an increasingly important consideration across the pharmaceutical industry, and PCI works closely with clients to identify opportunities to reduce environmental impact without compromising patient safety, product quality, or regulatory compliance.
“Within our device assembly and packaging operations, we support initiatives aimed at reducing material usage, improving packaging efficiency, and minimizing waste throughout the manufacturing process,” he says. “This includes evaluating packaging designs that optimize material consumption, reduce transportation volume, and improve overall supply chain efficiency. We also partner with customers and suppliers to explore more sustainable packaging materials where appropriate and feasible within the regulatory framework governing combination products.”
In addition, PCI continuously invests in operational improvements that enhance energy efficiency, reduce waste generation, and support responsible resource management across its global networks. These efforts are aligned with broader sustainability goals while maintaining the rigorous quality standards required for injectable therapies. “While sustainability remains an important objective, every decision must also maintain product quality, sterility assurance, patient safety, and regulatory compliance,” says Mr. Smallman. “Our goal is to help clients achieve both environmental and operational benefits without compromising the performance of their injectable therapies.”
Looking ahead, he says that what is most exciting is the convergence of advances in pharmaceutical development, drug manufacturing, and delivery device technologies. “We are seeing increasingly complex biologics, high-value specialty therapies, and novel formulations being paired with sophisticated delivery systems designed to improve the patient experience and support self-administration,” he says. “As biologics, specialty medicines, and personalized therapies continue to expand, we are seeing increasing demand for advanced autoinjectors, wearable injectors, and other delivery platforms that simplify administration while supporting adherence.”
At the same time, advances in connected health technologies are creating opportunities to integrate digital capabilities into injectable delivery systems. The ability to capture treatment data, support adherence monitoring, and provide real-time insights could further enhance patient engagement and outcomes. From a manufacturing perspective, PCI sees progress in automation, data analytics, and integrated supply chain solutions that can improve efficiency and product quality while accelerating commercialization timelines.