Contract development and manufacturing organization selection: critical considerations that can make or break your cell and gene therapy development

Abstract

Background aims: With the increase in cell and gene therapy (CGT) clinical trials in recent years has come a subsequent increase in the number of contract development and manufacturing organizations (CDMOs). Successful transition from development and early-phase clinical trials to commercialization of a CGT product often depends on selecting the best-suited CDMO. However, many CGT companies are small biotech companies that lack expertise in the field or do not have experience selecting and transferring a process to a CDMO.

Methods: Given the interest in this topic, a roundtable with CGT developers and CDMO members at the 2023 annual meeting of the International Society of Cell and Gene Therapy Paris discussed these critical aspects of product development, including technical expertise, risk sharing and timing of partnerships.

Results and conclusions: Here, we'll analyze the considerations discussed by the panel and elaborate on other factors crucial for CGT development.

Keywords: cell manufacturing; commercialization; process development; technology transfer.