The field of cell and gene therapy is transforming the way patients, diagnosed with cancers or genetic diseases, can be treated. These novel drug candidates provide drastically improved patient outcomes and, in some cases, can be curative. However, the manufacturing of such medicines pose complex new challenges. With small patient-scale batch sizes, centralized production using scale-up processes is no longer applicable and scale-out approaches become the norm. Today, the cost of production still represents a major hurdle on the way to the market. New technologies are needed that enable robust and cost-efficient manufacturing, and yield replicable high-quality medicines. While the therapeutic opportunities for patients are exciting, the stakes for patients and drug developers are high.
We want to be your partner in this process and drive pioneering therapies to the market. We invest in enabling technologies and build expertise to support the development and commercialization of your new innovative therapy. Our scientists and engineers bring decade-long development experience across a broad spectrum of cell types and technologies. This builds the backbone of an extensive service offering, providing you with tailored process and analytical development, manufacturing and regulatory services.
Our services are tailored appropriately to pace your investments throughout the clinical stage. We collaborate closely with you to align our services with your needs. We focus on the next milestone with your ultimate goal in mind.
More than 40 years of regulatory experience enable us to understand how to navigate the emerging therapeutics area. We were among the first to support commercialization of autologous therapies. This positions us well to advise you on regulatory strategies and prepare you for success.
Our services are based on an expanding portfolio of advanced technologies that enable robust, repeatable, and cost-efficient processes for cell and gene therapies. We continuously develop new solutions to meet the requirements of your future manufacturing processes.
The long-term supply strategy of a therapy needs to be determined while approval and market demand are still uncertain. You can mitigate your investment risk by partnering with us; flexible business models allow adaptation to different market demands.
In some cell and gene therapies, proximity to patients is a prerequisite for the delivery of treatment. We have a global network for cell and gene therapy with sites in Europe, North America and Asia, to ensure that your therapy is located where you and your patients are located.
Extensive experience with a wide variety of cells. Examples include embryonic stem cells (ESCs), mesenchymal stem cells (MSCs), induced pluripotent stem cells (iPSCs), neural stem cells, immune cells (T-cells, dendritic cells, natural killer cells), various tissue cells, and tumor cells.
Enabling solutions for both in vivo and ex vivo gene therapy. Experience with viral vectors like adenovirus, adeno-associated virus (AAV), herpex simplex (HSV), Newcastle disease virus (NDV), and lentivirus. We provide access to Anc-AAV synthetic vectors for potentially safer, targeted, and efficient transduction. If a non-viral gene transfer method is preferred, then our Nucleofector™ closed-system technology is available for research applications.
High-throughput, scalable production platforms for scalable, robust manufacturing operations. Our capabilities span across 2D systems (for example, CellSTACK™, HYPERFlask™, and Cell Factory™) to 3D computer controlled suspension bioreactors, optionally run in microcarrier mode for adherent cell culture. The Cocoon™ technology, currently under development in collaboration with Octane Biotech, is based on an automated GMP-in-a-box concept for autologous cell therapy manufacturing.
Are you looking for a reliable, experienced, and adaptive partner for your cell and gene therapy development? We have the capacity to manage projects from pre-clinical stage to commercialization successfully. Complete the form below to get in touch and let's meet the next challenge together.