Bridging Clinical And Commercial Needs

Gene therapy development is a complex journey, with thousands of therapies currently in progress worldwide. For many innovators, navigating from preclinical studies to regulatory approval can be daunting. Early development decisions are crucial as they can impact later stages, potentially causing delays due to gaps in the manufacturing process. Focusing solely on clinical development without considering product and process development can lead to significant setbacks.

This infographic provides three key considerations that allow for a proactive and agile approach to gene therapy development. These considerations help minimize delays and rework, ensuring a smoother path to market. Conducting risk assessments at each development stage is vital to identifying, prioritizing, and mitigating risk, thereby enhancing process understanding and preventing future revisions.

Learn how MilliporeSigma's viral vector CDMO services can provide comprehensive support, from research to GMP-grade plasmid supply, ensuring cost-effective and time-saving solutions. Their customer-focused approach and reliable supply chain network further streamline the development process.