Enabling a rapid and appropriate supply of drug products for Phase 1 clinical trials


By Kevin Kane, Global SME, Helen Danagher, Technical Specialist, and Ninette van Lingen, Director of Business Development, Thermo Fisher Scientific

Reducing the time between design and phase 1 trials can be particularly difficult for new and emerging biotechnologies. Since many of them are completely virtual or have limited lab space capabilities, they often lack in-house resources and capacity for formulation development. Without the ability to smoothly transition from laboratory concept to manufacturing and delivering GMP clinical supplies to patients, critical milestones could be missed, potentially delaying funding commitments from investors.

This internal capacity gap has led to huge growth in the CDMO market as more and more of these companies look to outsourcing for development at an early stage. The partner you select should have highly skilled and experienced people who understand your process, can work to solve complex problems, and will ensure that your molecule and product is manufactured using the most robust and efficient processes. These benefits give you the speed and flexibility that are essential early in drug development, while setting a clear path that will lead you to commercial success.

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