Gliding Towards De-Risked Combination Product Development

By Victoria Meyer, Senior Global Strategic Marketing Manager, BD Medical– Pharmaceutical Systems

The complexity and sensitivity of biopharmaceutical drugs require that specific care be taken in their development, manufacture and administration.

Because of the potentially heightened risk of unexpected interactions between the biologic drug product and its primary packaging, particular care must be taken when evaluating and selecting device materials and components. The price of unforeseen interactions can be steep, including potential product launch delays, as well as possible product recalls in the case of a combination product experiencing functional or safety challenges post-launch.¹

As a component of a combination product in constant contact with the biologic drug, the plunger stopper plays a critical role in determining the combination product’s exposure to extractables and leachables. Co-solvents, surfactants, chelating agents, bulking agents, pH modifiers and other formulation ingredients typically used to stabilize biologic drugs can have an impact on the leaching of organic compounds from rubber stoppers.²

As injection device designs evolve to accommodate a broadening range of challenging drugs, often requiring the mitigation of high injection forces for delivery, the plunger stopper has the potential to contribute to the combination product’s functional characteristics, including glide force, efficacy and safety. The choice of plunger stopper can also impact processibility and manufacturing, determining the component’s behavior and functional performance during the assembly phase, as well as its compatibility with existing assembly lines.

Here, Victoria Meyer, Senior Global Strategic Marketing Manager at BD Medical – Pharmaceutical Systems, introduces the BD SCF™ PremiumCoat® 1mlL Plunger Stopper and explains how the product’s role is critical in determining combination products’ exposure to extractables and leachables.