Health care providers and patients are frequently required to manipulate biological drugs prior and during administration. This might include procedures such as dilution of the drug into admixtures for infusion, limited storage, transportation to the hospital or exposure to new contact materials, such as intravenous bags.

The instructions for use are provided by the drug manufacturer and are based on studies to support in-use stability and compatibility with administration components, simulating drug handling and hold times throughout the defined in-use period. The studies are challenging, because there is a wide range of in-use conditions and administration components used globally. In addition, only limited guidance is available from regulators on expected in-use stability data.

In four workshops we will present and discuss industry approaches to assess in-use stability and compatibility for classic biological products as well as emerging trends. Each workshop is scheduled for 90 minutes, and includes 2 presentations followed by a discussion with the presenters and additional panel members.

Jing Liu

Appearances