細胞和基因療法產業的測試需求。
由於每個案件都有其獨特性，我們不斷與客戶合作開發新的測試。擴展細胞庫樣本，
並在 Qualtex 內部及其他合作夥伴實驗室進行測試，提供分析證書和結果報告。
- 服務項目
| Analytical Development |
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.
| Cell Line Characterization |
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.
| Expandability and Potency |
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.
|
Lot & Final Release |
We provide GMP compliant lot release testing programs designed to ensure the safety of your cellular therapy products. We have global regulatory expertise and can perform accelerated tech transfer/comparability studies.
| Stability Testing |
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.