As biologics steadily grow in pipeline development and commercialisation, inherently they require precise support to ensure effective delivery to the patient. In this article, Justin Schroeder, vice president for global programme management at PCI Pharma Services, looks at how to support the delivery of biologics through automated inspection systems.
Automation
Predominantly these medicines are delivered parenterally, and most commonly through injection. This may leverage traditional sterile vials, or increasingly methods such as prefilled syringes, or injectible systems leveraging a platform built out on prefilled syringe or cartridge as the sterile housing. Safety syringes, autoinjectors and pens, as well as more complex mechanisms for metered infusion, all leverage complex assemblies that work effectively and reliably due to extreme precision. These systems require this advanced precision in the moulding and fabrication of the various parts of the assembly, as well as utmost precision in both the subassemblies and final assemblies. In many instances this heightened level of sophistication is supporting a delivery mechanism that may be intended for only a single use. Conversely, multi-use pens inherently are designed to be used repeatedly or even refilled, and some applications such as diabetes may allow the user to customise their dosing in the delivery.
There is an impressive amount of intricacy and engineering architecture to make complex dosing systems effective and intuitive for the average patient. Many biologics and sterile injectable non-biologics still rely on traditional vials for patient administration. While we naturally infer that a complex autoinjector requires sophisticated automation and multilayered inspection, we do not necessarily infer that a traditional sterile vial in a kit may warrant the same.