With the significant progress in the development of individualized medicines, several issues with respect to their routine quality testing have emerged. As a new batch has to be tested for each patient, an extensive set of quality attributes to be analyzed and elaborate testing methods can be a challenge on both number of samples that are needed and the time that is required for testing. The latter is especially true for verifying the sterility of the drug product. As batches for individualized medicines cannot be stocked and the medical needs often require fast treatment of the patients, standard sterility testing can become the limiting factor for the success of an individualized therapy. In addition, it has to be ensured that the assays will function independent of the patient-specific aspects of the final product.

In this session, we will discuss key challenges and opportunities with respect to product quality testing for Individualized medicines to enable the successful development of such therapies.

Session Speakers:

USP Evolving Position on Use of Rapid Microbial Methods

Huiping Tu, United States Pharmacopeia

Defining Microbial Control Strategies for Cell-free and Cell-based Individualized ATMP's

Friedrich von Witzingerode, Genentech, a Member of the Roche Group

Delivering Next Generation Cell Therapy Manufacturing Faster without Compromising Quality

Scott Nichols, Kite, A Gilead Company

Additional Panelists:

Elvira Argus, CBER, FDA

Bryan Silvey, A2 Biotherapeutics, Inc.

Andreas Kuhn

Appearances