This professional QC laboratory is responsible for testing cell products produced in the Cell Preparation Facility, including raw materials, intermediate processes, and final products. It also provides testing services and consultation for external clients.
- Since April, 2011, multiple quality control tests have been accredited under TAF ISO/IEC 17025 certification.
1. Quality Control Testing
TAF ISO/IEC 17025–Certified Tests
- Sterility testing (direct inoculation and membrane filtration methods), bacterial and fungal inhibition tests (Chinese Pharmacopoeia 3071).
- Endotoxin testing, including inhibition/enhancement studies (Chinese Pharmacopoeia 3085).
- Mycoplasma detection, including method suitability testing.
2. Cell Surface Antigen Analysis
3. Automated Sterility Testing (Chinese Pharmacopoeia 5097).
4. Testing Consultation for related QC procedures.
1. Automated bacterial culture system
2. ABI Veriti PCR machine
3. Low-temperature incubators
4. Constant-temperature water bath
5. Pyros Kinetix® Flex system
黃國魁 經理
+886-3-5912177
light@itri.org.tw