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.

Quality from the start: preparing for a successful transition from Bench to Clinic

Discover more in our free Ibex® Design webinar

  • Does your CDMO stand behind its promises? We do by guaranteeing development & manufacturing timelines.

    Going from gene to IND as fast as possible is a clear objective for most biotech companies like yours. You are under pressure to shorten your timelines and move as quickly as possible: the next round of investment funding depends on hitting your targets.

    If you are looking to outsource, the available options need to be critically assessed. How can you ensure your service provider stands behind its promises and keeps timing without delays? How do you avoid a situation where you pick a fast service, but where you may not get the quality or quantity you need?

    The answer is simple. Chose a partner who provides a commitment on time, quantity and quality. Choose a partner who shares the risks with you. Work with the only CDMO that guarantees* to deliver GMP drug product for your phase 1 trials within 12 months, with an option to supply tox material in 9 months, and in addition ensures a minimum quantity of 1.5kg GMP drug substance material for your phase 1 clinical needs.

  • 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.

  • 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 program start from gene sequence or from cell line construction, and does it end with GMP drug substance, GMP drug product or with 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.

 

*For antibodies and antibody like molecules. From receipt of the gene sequence. Subject to terms and conditions.