Ibex® Design – Gene to IND in the fast lane

Ibex® Design is our fixed scope, fastest gene-to-IND offering, delivering GMP drug product for your clinical phase 1 trials within 14 months, with an option to supply tox drug product in only 9 months. To further increase predictability, we commit to a minimum quantity of 1.5 kg GMP drug substance material for your phase 1 clinical needs and 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.

  • Your next milestone on time, get your tox material in 9 months.

    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 get material for your 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 14 months, and an option to supply tox drug product in 9 months.

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.

How to address the expression and manufacturing challenges of increasingly complex biologic drugs?

To learn more, watch our webinar now

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.