Foreign Particulate Characterization Methodologies for Cell and Gene Therapy Products

Abstract

Background & Aim The presence and characterization of visible and sub-visible particulate present in parenteral products is a critical consideration during development, manufacturing, release and investigations. Established analytical methodologies for testing and regulatory guidance is well understood for pharmaceutical parenteral products, however, specific methodologies for cell and gene therapy products are not as mature. This discussion will focus on the various analytical methods used for visible and sub-visible particulate testing in injectable products. In addition, an evaluation of the current regulatory landscape for cell and gene therapy products will be compared and contrasted to pharmaceutical parenteral products. Several examples of data interpretation, analytical method selection and case studies in cell and gene therapy particulate characterization will be presented. The objectives of this presentation is three fold. The first is to familiarize the audience with current methods of pharmaceutical particulate testing for parenteral products and how these correlate to the testing of cell and gene therapy products. The second is to explain the inherent particulate in cell and gene therapy products, which makes interpretation and analysis more complicated in some cases. Lastly, a comparison of current guidance documents and USP methods established for parenteral products will be evaluated for cell and gene therapy products. Methods, Results & Conclusion The audience benefits of this presentation is a better understanding of current visible and sub-visible analytical testing methods for cell and gene therapy products. In addition, the audience will have a better appreciation for applying established particulate characterization guidelines as it pertains to cell and gene therapy products.