Plastic additive 11 is used to ensure the flexibility and strength of polymeric materials used in biologic formulations. It is a key excipient in biologics packaging, contributing to the longevity and stability of biologic drugs. By meeting USP reference standards, this additive ensures that biologics maintain their therapeutic efficacy throughout their shelf life.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.