The newest addition to the QualTex repertoire, our Cellular Therapy Testing service line, offers a full range of RUO, GLP and GMP qualified assays to support all Cell and Gene Therapy industry testing needs.
Because every project is unique, we are continually partnering with our clients to develop new assays. We can perform expansion on a cell bank sample and perform testing in-house and at qualified partner labs, providing a consolidated certificate of analysis and individual result reports.
We offer a comprehensive range of analytical testing services to characterize cellular therapy products. These assays can be customized and validated to meet specific needs of the client. We can also perform tech transferred assays developed by clients and validate them to meet GMP standards.
We perform a wide variety of cell line identity and authenticity assays and can develop custom cell-marker identification assays using flow cytometry or ELISA.
Potency determination is necessary for regulatory submission and lot release of cellular therapy products. We can develop custom potency assays or tech transfer client developed potency assays.
We provide GMP compliant lot release testing programs designed to ensure the safety of your cellular therapy products. We also have global regulatory expertise and can perform accelerated tech transfer/comparability studies.
We will assist clients in developing and implementing GMP study plans that meet worldwide regulatory requirements. We provide a controlled and documented plan for all of our stability studies, with thorough record keeping and reporting.
The robust integration process with our Quality team facilitates tech transfers and process development. Customizable quality processes include phase appropriate and risk-based testing solutions assuring the safety, purity, and potency of your cell-based products.