The right design and execution of clinical in-use and compatibility studies ensures the safety and the right quality of the administered drug product as well as success of your program.
Parenteral products need to be administered correctly, to ensure patient safety and product efficacy. This is to make sure that the patients are receiving the right dose of the active ingredient with appropriate quality. Hence, Health Authorities globally place a high emphasis on providing data to support the in-use stability and compatibility during administration of parenteral drug products. Many biological moieties can show different incompatibilities with administration device, including adsorption, precipitation, particle formation or glycation. Specific challenges can occur with products that have to be dosed in very low amounts and/or with very broad dose range, such as products under so-called “MABEL” dosing per European guidance.
With the large variety of options for administration devices and materials that are available for drug administration globally, this can become a daunting activity.
Our Drug Product Services (Lonza DPS) team has a wide has experience in this field, and can support in designing and executing the in-use and compatibility study and selecting the best options that ensure patient safety as well as clinical and commercial success of the program.