Formulation and Quality – Biomolecular
2019 PharmSci 360
The formulation of cell and gene therapy products poses major challenges due to their complexity, heterogeneity, interaction with their environment and susceptibility to degradation. These challenges can be quality, safety, and efficacy related. This presentation discusses the current status in formulation strategies of these complex biologicals and highlights the advantagesand disadvantages. Analytical tools for the characterization and stability of cell and gene therapy product formulations will be highlighted. In addition, unmet needs in the cell & gene product formulations will be touched base on.