Designing a Gene Therapy CMC Architecture for the Full Product Lifecycle

This guide gives gene therapy innovators a high-level perspective on the process development and contract services selection decisions to be made throughout the phases of development.

Process Development & Contract Services Decision Making

  • Speed to clinic or speed to market—process development ramifications
  • When should a CMC program begin?
  • Contract service organizations needed throughout your product’s development phases
  • Contract services partner selection considerations
  • Questions for a potential CDMO
  • Partnering with manufacturing services partners to optimize processes and address challenges
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BioTechLogic, Inc