For developers of cell and gene therapies (CGT), translating a drug from a biological concept to a scalable and manufacturable treatment can be the largest challenge in achieving commercial success. This is especially difficult in the CGT field, because there is a limited number of qualified personnel with both biological and process engineering know-how. Other challenges are evolving regulatory constraints and aggressive timelines from investors.
Even for experienced teams, it can be tricky to balance the efforts of reaching the first clinical trial using a manual, open method with building a more commercially suitable process. To accelerate their clinical and commercial programs, companies are choosing to work with contract development and manufacturing organizations (CDMOs). In this article, we highlight key areas where CDMOs can help companies get started in the world of CGT manufacturing. We also discuss when to engage with CDMOs to maximize commercial and clinical success.