Ibex® Design – Guaranteeing time and product quantity

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 including guaranteed deliverables. To further increase predictability, we keep a manufacturing slot reserved for your clinical resupply. 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

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

  • 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.

How can time to the clinic be reduced and yet a drug candidate be equipped with a robust CMC-package from day one?

To learn more, watch our webinar now

Lightpath™ – Finding a stable & commercially viable cell line quickly

The Lightpath™ program is designed around speed, which is achieved in part by screening fewer clones. This option is applicable for standard format antibodies and Fc-fusion proteins that have a low risk manufacturability profile. Manufacturability assessment is performed with a rapid in silico evaluation to ensure the molecule is appropriate for this offering. Lightpath™ aimed at rapidly and cost effectively progress your candidates to a stable, commercially viable cell line. Lead cell line candidates can be selected at 12 weeks from transfection.

How to de-risk the process development and manufacturing of multi-chain biotherapeutics?

To learn more, watch our webinar now.

Full Scope – Finding the cell line delivering optimal titer and critical product quality attributes

The Full Scope offering is suitable for customers targeting higher titers. For example, products targeting the neurodegenerative disease market will require large quantity of product. We will screen more clones to find the highest titer clone. This program is also suitable for complex proteins that can be difficult to express. Our Full Scope Cell Line Development service includes comprehensive clone generation and selection with supporting analytics to ensure high yielding cell lines that fit with the GS Xceed® Platform manufacturing process. Lead cell line candidates can be selected at 16 weeks from transfection.

Multiplex – Dealing with uncertainty

The Multiplex program is designed to progress multiple candidates or variants to the Research Cell Bank (RCB) stage. This offering progresses multiple candidate cell lines simultaneously so that the most suitable can be selected for the final lead. More data on variants/candidates can be generated and analyzed with Multiplex CLC to support your decision-making process for the best candidate. Lead candidate cell lines for up to four candidates/variants can be selected at 12 weeks from transfection. Multiplex CLC can save 4 months on an overall development program compared to a traditional biologics development approach.