Seamless transition from clinical to commercial manufacturing

 

Accelerate your market readiness with Ibex® Develop. From the start of process characterization, we can help you achieve your BLA submission in just 22 months. Clinical and commercial production are under the same roof, which simplifies comparability requirements and eliminates the need for tech transfers between sites. Additionally, you can commercialize from the same bioreactor that you used for production of your clinical material. Our regulatory experience could help you to de-risk your filing.


  • Why is one point of contact better than three?
    Answer:

    To achieve important development milestones as quickly as possible, many companies partner with different service suppliers with various capabilities and expertise. This includes cell line construction, process development, and manufacturing capabilities.

    The challenge to this is that it involves managing separate-but-related project elements—and suppliers—that make your development and management efforts more complicated and can consume tremendous amounts of time and resources.

    In addition, failure to manage a program holistically can create vulnerabilities—like cell lines that are not commercially viable, or processes that are not scalable. This can force cycles of rework causing delays, which can endanger future funding or give your competitors an edge.

    Consolidating everything under one roof is easier to negotiate up front, easier to manage over time and faster to process overall. An experienced partner with integrated drug substance and drug product capabilities can support you holistically. Together, you can create a development strategy with the end in mind.

    Compared to outsourcing work to several companies, working with just one is likely to shave several months off your timeline, as well as save on costs.

     

    Welcome to Ibex® Solutions.

    Ibex® solutions consist of three CDMO offerings: Ibex® Design, Ibex® Develop and Ibex® Dedicate that span the complete biopharmaceutical lifecycle- from preclinical to commercial stages, from drug substance to drug product, all in one location. The variety of solution offerings provide the flexibility of a complete program - from gene to drug product, or the option to drop in at a later stage depending where you are in your journey.

    Learn More

  • Answer:

    Some people say that a good partnership is best built between equals. However, as a small biotech you may not find a suitable CDMO partner with a similar size as your company. What are the options then for a small, agile business? You need a high-quality outcome but you want to keep your options open and avoid painting yourself into a corner. The good news is that you don't have to.

    By leveraging the expertise of a large, experienced CDMO in the right way, using the right business model, you can maximize the attractiveness of your program whatever your future strategy might be. This includes using a platform process that will facilitate regulatory approval and advanced manufacturing techniques that maximizes your chances to succeed.

    By doing this, you’ll accelerate your path to market while simultaneously positioning your candidate well for future milestones. This enables you to hit important inflection points on time, giving you the power to preserve all of your options—whether that is selling, partnering, or commercializing your drug with or without your CDMO.

     

    Welcome to Ibex® Solutions.

    Ibex® solutions consist of three CDMO offerings: Ibex® Design, Ibex® Develop and Ibex® Dedicate that span the complete biopharmaceutical lifecycle- from preclinical to commercial stages, from drug substance to drug product, all in one location. The variety of solutions offerings provide the flexibility of a complete program - from gene to drug product, or the option to drop in at a later stage depending where you are in your journey.

    Learn More

  • Answer:

    The pace of innovation has accelerated rapidly in recent years. Simultaneously, the attractiveness of the biopharmaceutical market has drawn new players and competition is growing. It is therefore increasingly difficult to stay ahead of the competition. The first to market gets the biggest share and no biotech company wants to be the second in line.

    To be a winner in the race to market you need a solid development strategy and an experienced partner. This is because maximizing the value of your new molecule is about more than speed. It is also about building your CMC correctly from the start, to create a commercially viable and scalable process. This is to ensure that when you have your BLA approved, your COGS have been optimized, you have enough capacity (even if your demand would change), and your process is robust and repeatable.

    Working with a partner with proven experience in taking products to market will help you solve the development equation. It can help you secure future commercial supply too.

     

    Welcome to Ibex® Solutions.

    Ibex® solutions consist of three CDMO offerings: Ibex® Design, Ibex® Develop and Ibex® Dedicate that span the complete biopharmaceutical lifecycle- from preclinical to commercial stages, from drug substance to drug product, all in one location. The variety of solutions offerings provide the flexibility of a complete program - from gene to drug product, or the option to drop in at a later stage depending where you are in your journey

    Learn More