Ibex® Design 2.0 is a new comprehensive program combining speed, guarantees* and quality while minimizing risk, in the delivery of your CMC path to IND in only 11 months for your monoclonal antibodies.
If you are looking to gain maximum information on your drug candidate as early as possible, Ibex® Design delivers tox drug product in only 5 months so that you can perform toxicological studies before entering GMP manufacturing.
Our parallel cell line and drug substance process development, as well as our integrated drug substance and drug product program, are key to bringing your rapidly quickly to the clinic. In addition, our step-by-step development strategy will allow balancing your program’s speed to your funding milestones.
Once you enrol in our Ibex® Design program, we will keep a manufacturing slot reserved for your clinical resupply and offer flexible drug product manufacturing, to further increase predictability in achieving timelines and material supply.
*For antibodies. From DNA transfection. Subject to terms and conditions.
We are equipped to support your molecule’s progression by overcoming barriers or finding innovative solutions using advanced technologies.
The quality of our early material generated from stable pool is representative of material generated later in the workflow from the selected clonal cell line (research cell bank). This allows us to use pool material to develop the purification process and formulation as soon as possible, achieving a parallel cell line and drug substance process development. This is one of the key elements to save time early, without increasing development risks, and help you accelerate your path to clinic.
We implement this platform development approach combined with state-of-the-art process platforms with the end point in mind, to ensure a direct and seamless transfer to cGMP manufacturing at 1 kL scale.