At Xellera, we understand that the clinical and commercial success of cell and gene therapy products heavily hinges on the successful development of robust, reproducible, and scalable manufacturing processes, in addition to the years or even decades of scientific research. With the extensive experiences and know-how, Xellera aspires to provide our partners an one-stop solution to cGMP manufacturing, spanning from early process development to manufacturing and bioanalytical testing, product release as well as cryostorage.
Process Development
Custom Manufacturing
The development of an efficient manufacturing process is critical to ensure that safe and high-quality cell and gene products are available for the patients as approved registered therapeutics or experimental medicine for clinical trials. Xellera has a portfolio of solutions for early-stage development all the way to larger-scale commercial production. With our in-house capabilities, we provide you with the infrastructure with hardware, software and expertise for a scalable, robust manufacturing process so as to efficiently take your cell- and/or gene-based therapeutic product to the patients.
Please see our technologies for CAR-T, Clinical-grade iPSC haplobank and MSC as examples of what our facility can manufacture.
Email us at [email protected] to discuss with our experts about your needs and goals.
Bioanalytical Testing
Cell-based therapeutic products have a limited shelf-life. Xellera Therapeutics provides in-house testing services for cell and gene therapy products covering characterization, safety, purity and functional testing for starting and raw materials as well as in-process and finished products. These analytical tests are crucial for allowing fast and efficient product release.