One-stop Central Lab Services
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Flow Cytometry
The flow platform follows GLP/GCP guidelines and is equipped with a variety of flow cytometers including Beckman Dxflex and Navios, BD CantoII, and is equipped with an advanced data acquisition system that enables up to 3-laser 13-color flow cytometry analysis. The flow platform focuses on CAR-T and oncolytic viruses and other cell and gene therapy, antibodies, ADC and other drug related pharmacokinetics (e.x., CAR quantity), disease classification (e.x., lymphocyte subset analysis and residual MRD in minimal lesions), cytokines (e.x., test of IFN-α and antidrug antibody receptor occupancy). In addition, based on the most advanced new flow cytometry analysis technology, the flow platform can describe the characteristics of tumor cells and subjects' immune status from the level of biomarkers, explore target development in clinical trials to provide new data support to translational clinical research. Verification of cellular immunotherapy, antibody drug therapy and traditional drug therapy, immune assessment, high-throughput screening, etc. can be performed through the flow cytometry platform. At present, the platform has provided flow cytometry services for a number of innovative drugs, including China's first marketed CAR-T product "Yescarta" and the first FDA-approved Chinese pharmaceutical company designed and developed "CARVYKTI".
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Routine Test
The Routine test platform has repeatedly passed the NCCL inter-laboratory quality assessment, the US CAP, and obtained the US NSGP (glycated hemoglobin) first-class laboratory accreditation, providing biological sample testing and analysis services that fully meet the quality requirements of CAP, NMPA, and GCP. Equipped with fully automatic biochemical analyzers, automatic chemiluminescence analyzers, whole blood cell analyzers, glycosylated hemoglobin and other testing platforms, relying on the sample management and supplies assembly supporting services of the central laboratory, connected by efficient logistics with major research centers and Teddylab central laboratories, the conventional laboratory can strictly provide standardized, methodologically validated safety assessments and efficacy assessments for clinical drug trials. The conventional laboratory is committed to providing customers with 24/7 safety assessment and clinical testing solutions, services covering automated chemistry, hematology, immunology and special chemistry, etc. to provide professional support for clinical research of diseases such as hepatitis, endocrine, diabetes, infection, tumor and metabolism.
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Pathology
The pathology platform includes a complete set of histopathological sample preparation systems, liquid-based cytopathological sample preparation instruments, automatic immunohistochemistry, a variety of special dyeing techniques, automatic staining and sealing equipment and other automatic pathological technology equipment, as well as automatic scanning test equipment, upright fluorescence microscope and other image analysis equipment, professional pathologists providing image reading and remote pathological image reading services, and professional molecular pathology personnel providing molecular pathology test services. The platform enables high-quality pathological reading services for pathological diagnosis, biomarker test, subject screening, and efficacy evaluation in clinical trials. Teddylab has also built a digital pathological image analysis platform based on HALO/HALOLink which adopts parallel analysis and processing technology compatible with most digital image formats, and provides analysis of multiple immunofluorescence staining. Teddylab can analyze clinical trial mIF image data and conduct deep mining and biomarker analysis via this platform. The web browser-based remote pathology consultation website: www.teddyeye.com is used for central pathology consultation in clinical trials. It enables pathology experts in the hospital to conduct pathological diagnosis remotely, flexibly deploys China's top pathology expert resources for clinical trials of oncology drugs, and efficiently provides technical and information support for pathological consultations. At present, more than 10 clinical trial samples have been analyzed for 5 pharmaceutical companies and biotechnology companies, and the cumulative number of samples tested exceeds 1,000.
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Genomics
The genomic lab provides biological sample analysis services that comply with relevant technical guidelines of NMPA, FDA, EMA, and ICH and meet the requirements of GLP specifications. Teddylab has built a world-leading test technology platform, including PCR instruments, fluorescence quantitative PCR instruments, digital PCR instruments, first- and second-generation sequencers, molecular hybridization instruments, etc. to provide testing services of drug safety, biomarkers, subject screening, PK, efficacy evaluation, etc. for non-small cell lung cancer and colorectal cancer in clinical drug trials, breast cancer, lymphoma and other tumor drugs, as well as anti-covid-19/hepatitis B/hepatitis C/RSV/HPV and other antiviral drugs and vaccines, nucleotide analogs, CAR-T and oncolytic viruses and other cell and gene therapy drugs, and to provide evaluation basis for current popular drugs and vaccine registration applications.
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2000+
Central Lab Test Menu
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480+
Laboratory Developed Test
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6+
CAP Accreditations
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1100+
Clinical Trials
Comprehensive Lab Service Capability
- Central laboratory
- Genomics
- Pathology
- Routine Test
- Flow Cytometry
- Bioanalysis
- Large molecule Bioanalysis
- Small molecule Bioanalysis
- Translational medicine
- Project and data management
- Sample and Labkit management
- Extended Lab Management
Integrated laboratory solutions for clinical trials
Provide central laboratory data for the clinical research and development as well as NDA of new drugs, covering biomarker discovery, method development and validation, clinical verification and application, etc.