In this white paper, Mathias Kahl, Head of Development at IDT Biologika, explains why commercial thinking should start during the earliest stages of clinical development. Decisions around CMC strategy, manufacturability, scalability, analytical methods, and supply chain planning can have a major impact on long-term success.

IDT Biologika helps customers develop GMP-compliant manufacturing processes that support future commercial supply. The discussion highlights the importance of evaluating process robustness, material availability, cost of goods, and technical feasibility early, particularly for complex modalities such as viral vectors, cell and gene therapies, and oncolytic viruses.

The white paper also addresses risk management, supply chain resilience, and integrated end-to-end services spanning development through commercial manufacturing. The key message: successful therapies must not only demonstrate clinical benefit but also be manufacturable reliably, efficiently, and at commercial scale. Early CMC planning is critical for long-term success.