Testing Laboratory

Testing Laboratory
Testing Laboratory
GTESTing® Laboratory

GTESTing® Testing Laboratory: Quality Testing Services

Laboratory Certification Number: 2800

 

GTESTing® Testing Laboratory, certified by the Taiwan Accreditation Foundation (TAF) since 2013, is dedicated to providing comprehensive quality testing services for cell therapy products. We maintain impartiality and independence, ensuring our tests meet the latest regulatory standards and industry needs. Our services support regenerative medicine, the pharmaceutical industry, and biotechnology research, aiding the development of the pharmaceutical industry.

 

Key Features:

Advanced Facilities: Equipped with state-of-the-art testing instruments,
clinical-grade equipment, and independent testing spaces, we provide stable, accurate, and rapid technical supports.

Automation and Quality Management: We are developing a fully automated testing system and an information-based quality management system. This approach reduces manual operations, simplifies processes, improves efficiency, and enhances quality control.

Expertise and Training: Our laboratory integrates medical laboratory and biotechnology talents, offering pre-service and in-service education, training, and assessment authorization systems. We focus on developing clinical laboratory medicine technology and molecular biological testing.

Comprehensive Testing Services: We offer a range of services including cell therapy product testing platforms, cell quality identification, peripheral blood stem cell analysis, rapid microbial testing, cytokine analysis, and immune functional assays. Our professional package services emphasize comprehensive integration, simplifying inspection processes, and accelerating testing time.

 

With the growing importance of regenerative medicine and intense international competition, GTESTing® supports the cell therapy companies by providing trusted quality testing reports. Our "Clinical Cell Preparation Quality Testing Service" has assisted numerous cell therapy clinical trials in Taiwan. We aim to expand our services internationally, setting a gold standard for Taiwan's cell therapy industry. Possessingrigorous quality control and cutting-edge testing capabilities, GTESTing® Laboratory contributes to advancing the cell therapy industry and fostering confidence among clinicians.

 

Item Testing Method Sample type
Endotoxin   -  TAIWAN PHARMACOPOEIA (3085) BACTERIAL ENDOTOXINS TEST
  -  USP, (85) BACTERIAL ENDOTOXINS TEST
  -  Cell Therapy Product
  -  Cell Culture Medium/Suspension/Supernatant
  -  Cell Biological Product
  -  Extracellular Vesicles
Mycoplasma Tests   -  TAIWAN PHARMACOPOEIA (5063) MYCOPLASMA TESTS
Sterility Tests (Direct Inoculation)   -  TAIWAN PHARMACOPOEIA (3071) STERILITY TESTS
  -  USP, (71) STERILITY TESTS
Sterility Tests (Automated Culture Systems)   -  TAIWAN PHARMACOPOEIA (5097) MICROBIAL EXAMINATION OF CELL-BASED PREPARATIONS
MSC Surface Marker Test   -  In-house method: SOP of MSC Surface Marker Test (Document No.: 3-13-031)
  -  CD14、CD19、CD34、CD45、CD73、CD90、CD105、HLA-DR
  -  Mesenchymal Stem Cell

 

Quality
Quality
Quality Certification
TAF認證
TAF
ISO/IEC 17025:2017;CNS 17025:2018 
國璽實驗室生物風險管理系統
Laboratory Biorisk
Management System
臨床細胞製劑品質檢測服務SNQ
SNQ Quality Certification
Clinical Cell Product Testing Services
Proficiency Testing
Proficiency Testing
Proficiency Test Certificate
Gtesting能力試驗證書
Gtesting能力試驗證書
Gtesting能力試驗證書
Gtesting能力試驗證書

Press Releases

Press Releases
NEWS
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