Advancing biotherapeutics from late stage discovery into the clinic is a critical step in drug development. However, developing a new molecule is not only about speed. It is also about managing complexity in the clinical journey by setting relevant milestones. You want to gain a maximum of information on the product as early as possible so you can make the right decisions on time.
Does your CDMO offers options to meet your milestones? Engage with a team of experts who can help you to plan all key steps of your clinical journey and take your project seamlessly from cell line development to IND and beyond. You can either start with a fast track program from gene to IND in 12 months, or insert a milestone for tox studies at 9 months. For example, performing toxicological studies before entering GMP manufacturing can take time, but such milestone approach minimizes risks. A step-by-step strategy also allows balancing your program’s speed to your funding milestones.
Ibex™ Design is a pioneering gene to vial offering delivering GMP drug product for your clinical phase 1 trials within 12 months, with an option to supply tox drug product in 9 months. To ensure speed to your milestones, Lonza guarantees the timelines of product supplied*.
*For antibodies and antibody like molecules. From receipt of the gene sequence. Subject to terms and conditions.