Accelerate Your Flight Plan To Market

The cell & gene therapy industry has experienced rapid progress over the last few decades, with many cell & gene therapy companies reaching the final destination: commercialization. Due to scientific advances, higher availability of clinical data, diversified technology platforms, and evolving regulatory standards, the promise that cell therapy brings is more certain than ever before. But as more therapies advance through clinical trials stages, late-phase issues repeatedly arise, hampering progress toward commercialization.

A recent McKinsey analysis of available data on late-phase cell & gene therapy development programs beginning Phase 3 trials (2016-2021) indicates that a large portion of programs faced chemistry, manufacturing, and controls (CMC)- and safety-related disruptions. Many programs are stalled due to comparability, analytical, or manufacturing site inspection issues. Deficient initial strategies for reliable starting and raw material sourcing, analytical manufacturing process design, formulation or management of the quality systems associated with the supply chain can lead to costly and time-consuming changes.

Selecting a manufacturing partner with a robust quality system and onsite quality assurance and control is necessary. Having an integrated manufacturing partner that provides critical starting materials can offer better control starting material profiles and reduce batch failures. Discover how to avoid clinical development pitfalls and choose the right cell therapy manufacturing path to clinic.