By Kevin Kane, Global SME, Helen Danagher, Technical Specialist, and Ninette van Lingen, Director of Business Development, Thermo Fisher Scientific
Reducing the timeline from conception to Phase 1 trials can be especially challenging for new and emerging biotechs. Since many of them are completely virtual or have limited lab space capabilities, they often do not have in-house resources and capacity for formulation development. Without the ability to move smoothly from lab concept to the manufacture and delivery of GMP clinical supplies to patients, critical milestones could be missed, potentially delaying funding commitments from investors.
This in-house capability gap has led to tremendous growth in the CDMO market, as more of these companies are turning to outsourcing for early-stage development. The partner you select must have highly skilled and experienced people who understand your process, can work to solve complex challenges, and will ensure your molecule and product are manufactured using the most robust and efficient processes. These advantages give you the speed and flexibility that is critical in early drug development while also establishing a clear path that takes you all the way to commercial success.