Gene to IND with guarantees and milestones.
Progressing from Gene to IND is a clear goal for biotech companies like yours. You need a comprehensive CMC program to hit this milestone: but what does it mean? Where such service offer starts, where does it finish, and how fast can it be? Do 7, 9 or 12 months-programs contain everything you need for your IND submission? Does a fast timeline start from gene sequence or from cell line construction, and does it end with GMP drug substance, GMP drug product or also with an IND ready documentation including stability study results?
Let’s avoid confusion. It is easy to get clarity by selecting a CMC program that offers both fast timelines and a complete IND package from A to Z: from gene to submission ready CMC package within 12 months, and an option to supply tox drug product in 9 months.
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.