Getting to IND is a make-or-break milestone for biotech companies. You are under pressure to condense your timelines and move as quickly as possible. At the same time, you are neck-to-neck against competitors who are focused on the same targets as yours. The next round of investment funding depends on hitting your goals.
However, maximizing the value of your new molecule is about more than speed. It is also about building the CMC correctly from the start. Failure to manage a program holistically can create vulnerabilities. This includes cell lines that are not commercially viable, or processes that are not scalable. In turn, this can force cycles of rework and delay.
What is the point to rush to the clinics if the processes that got you to this point can’t be scaled to move smoothly to the next stages? This is why speed to IND is not critical - if this means compromising on quality and commercial viability.
Ibex™ Design is a pioneering gene to vial package delivering drug product for your clinical trials within 12 months. Also included is manufacturing slot reserved for your clinical resupply needs.