Implementing Medium And High-Volume Drug Handling And Packaging Programs

By Kyle Eyster, Operations Manager; Shane McDermott, Senior Manager, Program Management Operations; Catherine Murphy, Director, Quality and Compliance; and Madhu Raghunathan, Senior Director, Business Development and Market Strategy

Bringing a combination drug–delivery product to patients involves a highly complex series of steps beyond the drug development cycle itself. A critical decision for drug originators is whether to adopt an existing platform device or invest in designing and developing a fully customized solution from the ground up.

While a bespoke device can offer clear advantages in performance and differentiation, it also places a substantial operational and technical burden on pharmaceutical companies. Organizations must manage the full scope of industrialization, including design for manufacturing and assembly, alongside clinical and commercial device production. This extends to integrating the drug and device into a single combination product and completing downstream activities such as labeling, kitting, cartoning, serialization, aggregation, and release testing — all within cGMP-compliant facilities, often requiring cleanroom environments.

Only after successfully navigating each of these interconnected phases can the product advance to clinical trials or, ultimately, be delivered to patients in hospital or home care settings.