Stability of Antineoplastic Biologics During Preparation (Stabzumab)

Description:

With hundreds of thousands of new cases each year, cancer represents not only a medical but also a significant economic burden on the healthcare system.

Monoclonal antibodies play a significant role as a central component of modern immunotherapies. These protein-based biologics are prepared on a patient-specific basis but are often discarded prematurely due to conservative shelf-life specifications. This leads to avoidable additional costs, particularly in the preparation phase. Reliable determination of the stability of these cost-intensive drugs is expected to contribute to a significant reduction in these expenses. A reliable stability assessment requires standardized analytical methods.

The goal of the project at IUTA e.V. is therefore to develop and establish such methods for the robust determination of the stability of a wide variety of biologics. The plan is to use two-dimensional analytical approaches that simultaneously measure physical, chemical, and biological parameters, thereby enabling a well-founded evaluation. In addition, validated protocols, product-independent evaluation software, and training concepts for pharmacies and research institutions are to be developed. The data obtained will be made freely accessible via established databases and, in the long term, contribute to reducing avoidable drug losses.