Tips For Managing GMP Manufacturing Timelines

Managing timelines is a shared challenge for contract development and manufacturing organizations (CDMOs) and their clients, with important implications for both parties. For cell and gene therapy developers, delays mean lost time and resources that can negatively impact the pathway to commercialization for their products. For CDMOs, delays impact capacity and resource planning.

CDMOs and their clients must work to understand and mitigate timeline risks so that there is minimal impact on project success. A CDMO’s project management (PM) team will be the client’s main partner in developing and managing timelines and holding various internal and external stakeholders accountable. Where needed, the PM team also serves to facilitate an escalation path to help resolve challenges. In this post, we will outline how the PM team can help manage timelines and avoid delays.