Pharmaceutical manufacturers need to understand the compatibility and performance of the primary packaging system with both the drug and its delivery system.
Jennifer Riter, West Pharmaceutical Services
As more pharmaceutical manufacturers develop combination products, they identify new and complex interactions among packaging components and delivery systems. Understanding this interplay is critical to developing a successful drug-device combination.
Different types and classes of drugs warrant varying approaches; for example, there are specific expectations around particulate in biologics due to aggregates, sub-visible and visible particles, potentially posing a risk to patient safety and product efficacy. For any drug, creating a risk-based testing strategy early in development is a key to ensuring success of a combination product.
This includes developing and applying a strategy for component and system qualification, which is critical to ensuring drug product quality, safety and efficacy. Not only do manufacturers need to understand the chemical compatibility of any given drug with its packaging components, but also how physical and functional aspects of packaging components and the device all come together and function as a system.