By Patrick Le Gal, R&D for Advanced Drug Delivery Solutions, BD Medical - Pharmaceutical Systems
The challenges associated with designing self-injection systems to deliver biological drugs (ie, biopharmaceuticals) into the subcutaneous space carries very specific challenges relative to those required for the safe and efficacious delivery of traditional pharmaceuticals. For example, biological drug formulations are often more viscous (up to 30 cp and more) and often require larger dosing volumes (up to 2 ml and beyond). These parameters often exceed the capabilities of traditional delivery methods and require new innovations, such as large-volume autoinjectors, that push design constraints to the limits of what is possible while challenging designers to manage competing requirements. In order to accommodate such advances, BD deployed a quality by design approach to manage all the unavoidable competing requirements and to propose a solution that balances performance, robustness, and usability. Two concrete examples of design optimizations and trade-offs are presented, highlighting the value of such patient centric development.