Biocompatibility tests

Q: What are the common biocompatibility tests that drug companies must perform during new drug development?

—Rupal Nguyen, Senior NPD Engineer, Microvention

A: Biocompatibility testing in conventionally delivered medicinal products is much simpler than for devices and suchlike that may be implanted directly into the body. The standards for evaluating the biocompatibility of medical devices is detailed in ISO 10993.
For conventional products, packaging technologists would explore the potential interaction between the product and its container. Common tests include leaching from plastics or adhesives on labels into the product, softening of containers through additives in plastics that may cause degeneration of the container, thus losing its protective function or degrading the active ingredient or creating harmful byproducts. Considerations then turn to delivery systems and any sensitization or allergenic potential.

—Helen Underwood, Director of Client Services, Fisher Clinical Services