Concise Review: Process Development Considerations for Cell Therapy

This article will provide a summary of what should be considered to efficiently advance a cellular therapy from the research stage through clinical trials and finally toward commercialization. The identification of the basic questions that affect process development is summarized in the target product profile, and considerations for process optimization are discussed. The goal is to identify potential manufacturing concerns early in the process so they may be addressed effectively and thus increase the probability that a therapy will be successful. Significance The present study contributes to the field of cell therapy by providing a resource for those transitioning a potential therapy from the research stage to clinical and commercial applications. It provides the necessary steps that, when followed, can result in successful therapies from both a clinical and commercial perspective.
Source: Stem Cells Translational Medicine - Category: Stem Cells Authors: Tags: Concise Review, Standards, Policies, Protocols, and Regulations for Cell-Based Therapies Source Type: research