Viral gene transfer vector manufacturing for in vivo and ex vivo applications has largely been in support of early phase clinical trials, but as product candidates move to later development stages, demand is rapidly increasing for commercial grade vectors at a variety of scales. Decisions regarding vector design, manufacturing platform, product configuration, process control, and regulatory strategy have an impact on timelines and resources, raw materials sourcing, and analytical testing. Developing a strategy that supports an efficient path to commercialization while reducing risk helps to bring these cutting edge cell and gene therapies to patients in need.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
• QA/QC analysts
• R&D scientists, managers
• Team members in CMC development projects
• Manufacturing and process development scientists, managers
• Regulatory affairs specialists
• Contract research organizations
• Contract manufacturing organizations