Key Objectives
- Learn about the key obstacles gene therapy innovators face, including rapid advancement to first-in-human studies and navigating regulatory approvals.
- Discover approaches for speeding up process development to achieve efficient, scalable GMP manufacturing for phase 1 clinical trials.
- Identify essential criteria for selecting the right CDMO partner.
Advanced therapy developers, particularly in the cell and gene therapy space, face intense pressure to balance speed, cost, and GMP compliance as they move from early research into the clinic. An experienced CDMO can mitigate these challenges by offering stage-appropriate support, platform technologies, and flexible manufacturing approaches that accommodate both early academic processes and more mature, transfer-ready programs. Hartmut Tintrup, Executive Director, Commercial Development, FUJIFILM Biotechnologies, highlights how establishing a trusted, financially stable partner with end-to-end capabilities early on can reduce tech transfer risk and enable a smoother path to commercial manufacturing.