Contract development and manufacturing services to serve the global market
Contract Development & Manufacturing Organization Services: Helping Manage Growing Demand
Exciting next-generation cancer medicines, such as cell and gene therapies, are providing significant new breakthrough opportunities for both small and large life science organizations in the space.
With thousands of preclinical and clinical trials for innovative cell therapies currently being conducted, the need for quality and reliable CDMO services are at an all-time high. But who can you trust to help you navigate the constantly evolving regulations and requirements, while controlling costs?
ThermoGenesis is building a state-of-the-art facility with CDMO capabilities and plans to help address the ever-evolving manufacturing needs of organizations in the cell therapy field. Our goal is to help accelerate drug candidates to clinics as quickly and safely as possible. Our focus will be to establish solutions for streamlining your supply chain, increase manufacturing predictability and manage overall risk. Our line of products and services shall be specifically designed to provide the flexibility needed to deal with uncertainty at every stage of the process.
Utilizing our unique and comprehensive cell therapy portfolio, we plan to include a wide range of expertise across a variety of cell types including chimeric antigen receptor T cells (CAR-T), T cell receptor (TCR), tumor-infiltrating leukocytes (TILs), natural killer cells (NKs), induced pluripotent stem cells iPSCs, and mesenchymal stem cells (MSCs).
Whether you’re looking to manufacture multiple batches or cGMP material for clinical trials, we can help you accelerate your strategic goals with full transparency.
The Unmet Need for Cell Therapy Manufacturing
The drug costs for CAR-T cell therapies currently approved in the U.S. are approximately $373,000 to $475,000 per dose, making them among the most expensive drugs in the market; manufacturing cost for each dose of some CAR-T therapeutics exceeds $100,000, 79% of which can be attributed to labor and GMP facility costs.
The ThermoGenesis Solution
CAR-TXpress™ Platform - ThermoGenesis Proprietary Cell Manufacturing Technology
With revolutionary cell-based therapies, such as CAR-T for cancer treatment, becoming a reality, developers must address a key challenge — how to manufacture high-quality, clinical-grade cell therapies at a commercial scale that will allow these groundbreaking treatments to be available to as many patients as possible. The CAR-TXpress Platform has the potential to reduce processing time significantly, improve cell recovery, and significantly reduce the manufacturing cost for CAR-T and other cell and gene therapies.
Traditional cell processing methodologies involve manual processes that are both labor intensive and time consuming which presents a significant obstacle to the large-scale manufacture of CAR-T cell therapies. In contrast, our proprietary CAR-TXpress™ platform, a multi-device automated solution that selects target cells using its patented buoyancy-activated cell separation (BACS) technology is designed to automate and standardize many of the manual steps involved in cell processing and free of user variability.
The platform eliminates the use of Ficoll for cell isolation and replaces the magnetic-based systems used for cell selection procedures with a buoyancy-based one. This proprietary platform reduces the manufacturing time and cost involved, while creating a viable and scalable cell product. The CAR-TXpress™ Platform provides a comprehensive automated cellular manufacturing and control solution for the development of CAR-T cell therapies.
Global GMP Manufacturing Network
By establishing efficient and effective processes in our manufacturing facilities, ThermoGenesis will assist you with streamlining and enhancing your manufacturing process. We will help you manage process flexibility, create a rapid process scale-up plan for early-stage clinical products, while standardizing the entire process and reducing manufacturing costs.
Our cGMP manufacturing facility and staff will be providing development and manufacturing services support to companies looking to scale-up in the cell therapy space.
We are here to work with you, and look forward to answering any questions you may have about our upcoming CDMO service solutions. Our services are customized to enable our clients to meet their strategic goals in a streamlined manner, utilizing our time-saving and cost-effective processes.
Please contact our experts today to get started on a plan that is customized for your specific needs.