The newest addition to the QualTex Laboratories repertoire, the Cellular Therapy Testing service line, offers a full range of RUO and cGMP qualified assays to support all Advanced Therapies industry testing needs.
Because every project is unique, the team continually partners with clients to develop new assays. QualTex 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.
For inquiries about specific testing needs, please contact the team.
QualTex runs a variety of assays to verify that the cellular therapy product is safe so there is no contamination or safety issue for the recipient.
QualTex performs a wide variety of identity and authenticity assays and can develop custom cell-marker identification assays using flow cytometry or multi-plex ELISA. We offer a comprehensive range of analytical testing services to characterize cellular therapy products.
Potency determination is necessary for regulatory submission and release of cellular therapy products. The team also develops custom potency assays or tech transfer client-developed potency assays.
The collaboratively integrated process with our quality team facilitates new testing and new product introduction. Customizable quality processes include phase appropriate and risk-based testing solutions assuring the safety, purity, identification and potency of cell-based products.