The Developing Standards Landscape for Cell and Gene Therapies

Effective standardization strategies are critical to the successful development and adoption of complex technological solutions, in many cases due to meeting requirements of interdisciplinary expertise, interconnected systems, or the production of comparable products at scale. Cell and gene therapies, as a new generation of living drugs are a prime example of such a technology, yet with the pace of advance, the challenge to develop appropriate solutions is an increasingly complex and resource-intensive activity, requiring careful prioritization and management. This chapter introduces and develops various drivers for standardization in this sector, the stakeholders involved in this work, and governance structures required for standards development and deployment, helping to overcome challenges associated with product and process characterization, consistent manufacture and regulatory approval.