Discussion

Measurements are paramount for the development of cell therapies, supporting product and process characterisation and the submission of subsequent regulatory documentation. The huge costs associated with product development and manufacture also means that smarter analytical strategies are needed to support products through the clinical process towards market authorisation. This presentation will consider a cross section of challenges currently arising in this field. It will look at the design of robust testing strategies for obtaining reliable and comprehensive data which can be used to define critical quality attributes linked to phenotype and potency and evaluate existing or new Process Analytical Technologies (PAT). Effective implementation of this approach rests in part with the integration of multidisciplinary platforms. Moreover, the importance of understanding all aspects of assay performance will also be emphasised in the context of successful technology transfers, essential steps in the development cycles of such products. Finally, opportunities will be discussed in the perspective of de-risking and re-purposing current/future processes and cell therapies.