Gene to IND in 12 months guaranteed*
Ibex® Design is our fixed scope, fastest gene-to-IND offering, delivering GMP drug product for your clinical phase 1 trials within 12 months, with an option to supply tox drug product in only 9 months. To ensure speed to your milestones, we guarantee* the timelines of product supplied, and in addition commit to a minimum quantity of 1.5 kg GMP drug substance material for your phase 1 clinical needs. Lonza is the only CDMO offering a comprehensive gene to IND program with submission-ready CMC data for your IND/IMPD in 12 months with guaranteed deliverables. To further increase predictability, we keep a manufacturing slot reserved for your clinical resupply.
How to reduce timelines from gene to IND without increasing risk?
With increased speed, drug developers may inadvertently expose their program to additional time, costs, and regulatory risks. Companies need to consider which activities can be accelerated and to carefully plan how to reduce not only time to the clinic, but to also support the drug candidate with a robust CMC-package that will add value as it advances from one clinical phase to the next.
Lonza’s advanced gene to IND platform, Ibex® Design, achieves speed without adding risk and offers an optimal program profile for a seamless transition from gene to IND and beyond. Benefit from our proven GS Gene Expression System® and over 30 years of track record in cell line development to accelerate your path to the clinic without increased risk.