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CDMO Service
CDMO Service
GenCure 為創新療法領域提供各種支援服務，包含製程、檢驗分析開發、cGMP 生產、
製程確效及最終產品放行測試，同時藉由統一的品質管理系統，與客戶一同實現臨床
應用及產品商業化的目標。
製程確效及最終產品放行測試，同時藉由統一的品質管理系統，與客戶一同實現臨床
應用及產品商業化的目標。
服務項目
- 服務項目
| Custom Source Materials |
Access to cGMP and cGTP products for transfusion and transplant; cGMP for further manufacture in development selectively
| ● Perinatal tissues | ● Bone marrow-derived stem cells |
| ● Umbilical cord blood | ● Apheresis derived progenitor cells |
| ● Blood components | ● Mononuclear cells |
|
Development |
Transfer, development and optimization of cGMP-compliant scalable processes
| ● Cell therapy process development | ● Scale-up |
| ● Cell isolation | ● Downstream purification |
| ● Cell expansion | ● Formulation development |
| ● Cryopreservation |
| Manufacturing |
cGMP-compliant, phase-appropriate, manufacturing of advanced therapies
| ● Pre-clinical | ● Late phase and commercial |
| ● Early phase clinical-grade | ● Fill/Finish |
| Testing |
cGXP testing services performed internally and through qualified partners
| ● Sterility testing (ID and susceptibility) | ● Cell viabtiliy |
| ● Viral safety testing | ● Identity/purity testing |
| ● Cell characterization and authentication | ● Custom assay development |
| ● Potency testing | ● Method suitability |
| ● Lot and final product release testing |
● Plasma, blood, cord blood, tissue and organ donor safety testing |
| Storage and Logistics |
Management of cold chain processes for final products
| ● Optimization of controlled-rate freezing |
| ● Storage of products (LN2 vapor-phase, 2-8° C, -20° C, -80° C) |
| ● Validated shipping procedures |
|
● Continuous temperature monitoring during shipping |
| ● Maintenance of samples for stability testing |