Key drug-device combination product considerations through the clinical-to-commercial journey

It all begins with the patient and determining the optimal administration process for the drug product and its characteristics.

Assuming the objective is patient self-administration, there is a convergence of multiple considerations, including:

  • Human factors: Device selection based on suitability for the patient population. For example:
    • The two-step, single-use auto-injector, proven over several decades to be patient-friendly with ease of use through direct skin activation
    • The pre-filled injector pen, used primarily for insulin administration, which has additional steps compared to the auto-injector – namely the installation of a pen needle, dose selection and manual insertion of the needle
    • The on-body injector, which offers benefits of larger volumes and longer injection times, also requiring additional steps for attachment to the body with adhesives, plus the subsequent removal.
  • Primary container strategy: While there are exceptions, the general rules are:
    • Use of a pre-filled syringe as a stand-alone solution, with an added safety device, such as BD UltraSafe, or as part of an auto-injector
    • Use of cartridges with a pen, whether a pre-filled or reusable pen, noting that reusable pens offer environmental benefits as usage is typically measured over a year while requiring the patient to change the cartridge when empty
    • Use of on-body injectors provides multiple options for containers, including the use of vials, depending on whether it is a ‘push’ or ‘pull’ configuration.
  • Device strategy:
    • Use of established platforms: There are many well-accepted pens, auto-injectors and on-body injectors that have received regulatory approval as part of a drug-device combination product, and use of such devices may be deemed lower risk for a new program
    • Pursuit of device innovation: The use of a more innovative device may be deemed more attractive for specific patient populations compared to more traditional and readily available platforms.

In developing a path from clinical to commercialization, early evaluation of drug-device combinations is critical to ensure a patient-centric solution. Once the use-case and human factors are determined, reaching early decisions on primary container and device strategy during the clinical phase ensures minimal changes as the product progresses to commercialization, reducing programme risk and optimizing time and cost efficiencies.

Exclusive PharmaPack supplement with Bill Welch, Executive Director of Services at PCI Pharma Services | as seen in Pharmaceutical Manufacturing and Packing Sourcer | 2024.

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