The GTESTing® Testing Laboratory performs its analyses based on pharmacopoeias from various countries, national standards, international technical organizations, scientific journals, or methods designed and developed in-house. On October 17, 2013, the lab passed ISO/IEC 17025 accreditation from the Taiwan Accreditation Foundation (TAF), becoming an accredited laboratory in its field. The laboratory's operations and management comply with all ISO/IEC 17025 requirements. All test items undergo method validation, and quality is monitored using bioanalytical quality assurance methods. We also regularly participate in inter-laboratory comparisons and proficiency testing programs organized by relevant domestic and international institutions to ensure the highest quality of our tests./p>
TAF-Accredited Tests include Endotoxin, Mycoplasma test, Sterility test (both direct inoculation and automated growth methods), and Mesenchymal stem cell surface antigen detection.
General Test Items | |||
Test Items | Test Method/Methodology Basis | ||
Cell Product Characterization | 1 | Endotoxin | 【Kinetic Chromogenic Method】 • Chinese Pharmacopoeia (3085) Bacterial Endotoxins Test • USP, (85) BACTERIAL ENDOTOXINS TEST |
2 | Mycoplasma Test | 【Nucleic Acid Amplification Technology 】 • Chinese Pharmacopoeia(5063)Mycoplasma Test |
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3 | Mesenchymal Stem Cell Surface Antigen Detection | 【Cell Surface Antigen Detection】 • Mesenchymal Stem Cell Surface Antigen Detection Standard Operating Procedure (Document No.: 3-13-031) CD14、CD19、CD34、CD45、CD73、CD90、CD105、HLA-DR |
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4 | Sterility Test (Direct Inoculation Method) | 【Direct Inoculation Method】 • Chinese Pharmacopoeia(3071)Sterility Test • USP, (71) STERILITY TESTS |
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5 | Sterility Test (Direct Inoculation Method) Bacteriostasis and Fungistasis Validation Test |
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6 | Sterility Test (Direct Inoculation Method) | 【Automated Growth Method】 • Chinese Pharmacopoeia(5097)Microbiological Testing of Cell Therapy Products |
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7 | Suitability of Sterility Test (Automated Growth Method) | ||
8 | Gram Staining | 【Gram Staining】 • Standard Operating Procedure for Gram Staining Test (Document No.: 3-13-020) Rapid Screening of Microorganisms in Products Using Combined Gram Staining and Microscopy |
Special Testing Items | ||
Test Items | est Method / Method Basis | |
1 | Endotoxin(NEXGEN-PTS) | ※Rapid Test Method※ 【Kinetic Chromogenic Method】 USP, (85) BACTERIAL ENDOTOXINS TEST |
2 | Nanoparticle Tracking Analysis | 【Nanoparticle Tracking Analysis(NTA)】 Instrument:NanoSight NS300 Analysis: Particle Concentration and Size Distribution Test Article: Exosomes (exosome or extracellular vesicles) |
The submitting organization should assess the sample’s transportation and storage conditions, and then choose either hand delivery or shipment. The laboratory accepts samples until 16:00. If received after this time, the samples will be stored under appropriate conditions until processing.
The sample volume can refer to the recommended amount in relevant regulations (e.g., pharmacopoeia), or the laboratory can provide the minimum volume required for testing. The submitting organization should assess whether the sample volume is appropriate, or consult the regulatory authority if needed.