Testing Laboratory

Testing Laboratory

Testing Laboratory
Testing Laboratory
GTESTing Services

 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
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
4 Sterility Test (Direct Inoculation Method) 【Direct Inoculation Method】
• Chinese Pharmacopoeia(3071)Sterility Test
• USP, (71) STERILITY TESTS
5 Sterility Test (Direct Inoculation Method)
Bacteriostasis and Fungistasis Validation Test
6 Sterility Test (Direct Inoculation Method) 【Automated Growth Method】
• Chinese Pharmacopoeia(5097)Microbiological Testing of Cell Therapy Products
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)
Testing Request Process
Testing Request Process
Testing Service Workflow
Patent Portfolio Strategy
Quality
Quality
Quality Certification
Quality Certification of Testing Laboratories
Proficiency Testing
Proficiency Testing
Proficiency Test Certificate
Proficiency Testing Certificate for Testing Laboratories
FAQ
FAQ
Frequently Asked Questions
  • How should I submit the sample?

    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.

  • Sample Volume?

    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.

     

  • Report Issuance Time?
    The turnaround time depends on the testing items and is generally set at approximately 7 or 14 working days. If the submitting organization urgently requires the report, a scanned electronic copy can be provided via e-mail once testing and reporting procedures are completed. (Definition of working days: counted from the date the laboratory receives the sample, excluding national holidays.)/div>
     
     
     

Press Releases

Press Releases
媒體報導
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