This article describes these different characteristics with regard to the biopharmaceutical industry.

By Fran DeGrazio, Executive Advisor, Kymanox Corporation

Materials used in a drug package or device design are fundamental to ensuring a safe and effective drug development program. The recent growth in complex therapeutics has increased demand for sophisticated packaging and device designs as these products are extremely sensitive to their environmental and storage conditions. Device developers need to understand material properties of the various components and how those properties may be affected when interacting with the drug or other materials in the system.

The selection of materials used in a drug package and delivery system should be based on extensive testing, characterization of the system under various conditions, and backed by data. There should be a methodical approach to analyzing the data and to being able to justify all the choices made. Materials used in a drug package or device design are fundamental to ensuring a safe and effective drug development program. Ensuring that these justifications are in place early in development enables an easier regulatory approval process. The characteristics above are some of the most important aspects from a fundamental materials standpoint that should be considered as part of this process; however, for every system, a custom approach should be undertaken in order to meet its specific needs

Read More