NEW

CMC Expertise Accelerating Biologics Development for 20 Years and Counting

Working with my co-founders, colleagues, and clients on many fascinating projects over the last twenty years has been an honor. From the founding of the firm with former Pfizer colleagues until today, we have specialized in supporting the CMC and regulatory programs...
eBook

Designing a Gene Therapy CMC Architecture for the Full Product Lifecycle

Process Development & Contract Services Decision Making

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

  • 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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