Overview: Core technical elements for early product development, evaluation, and control of human cell-based products.

Essential scientific elements for early product development, evaluation, and control of human cell-based products for cell therapy are addressed in a comprehensive and unifying way. Among them, donor issues (autologous and allogeneic), testing of raw materials, cell banking and cell substrate characterization, testing for adventitious agents (viral safety), and product sterility are very much related to each other. A significant amount of expertise exists in these areas both for traditional biologicals as well as for biotechnology products. Thus, core principles/concepts as well as the testing methodologies are already well defined. Other critical technical elements that are essential but need further discussion in terms of relevant regulatory requirements and testing methods are touched upon very briefly and followed by a detailed discussion (elsewhere).