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Overview
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Services
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Featured Strengths
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Instrument Platforms
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FAQs
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Related Resources
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Related Services
Overview
Since 2006, we have established a long-term mutual trust collaboration model with pharmaceutical companies worldwide. With an experienced professional analysis team, advanced analytical instruments, whole-process electronic management, and reliable quality control systems, we continuously empower our customers with high-efficiency and high-quality bioanalytical services from screening stages to a clinical trial application that includes drug discovery, in vitro and in vivo pharmacokinetics and pharmacodynamics. We also provide high-quality customized services for the personalized needs of customers in large and small molecule drugs, biomarkers, immunogenicity, and cell-based assays.
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Services
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Small Molecules
Small molecule compounds, biomarkers, chiral compounds, metal containing compounds, and innovative drug delivery systems, etc.
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Novel Drug Modalities
Monoclonal antibodies (mAb), bispecific antibodies (bsAb), recombinant proteins, biosimilars, fusion proteins, peptides, antibody drug conjugates (ADC), Proteolysis Targeting Chimera (PROTACs*), peptides and proteins, hormones, oligonucleotides, gene therapy products and vaccines, etc.
Featured Strengths
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Seamless Upstream and Downstream Integration
From screening to IND application
One-stop full-process analysis service
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Comprehensive Service Types
Molecular weight range: 50 Da to 200K Da
100+ types of matrices
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Advanced Instrument Platforms
Automated sample pre-treatment system
High-sensitivity, high-resolution analytical detection platform
High-throughput sample analysis platform
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High-Quality Data
Dedicated instrument maintenance and quality control teams
Consistency verification across multiple sites, analytical platforms, and sample preparation methods
Compliance with IND application standards regulatory agencies such as NMPA, FDA, EMA, etc.
Instrument Platforms
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Mass Spectrometer
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Ligand Binding
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Nucleic Acid Detection qPCR
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Full Automation, High-throughput
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Waters Vion™ QTof
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Orbitrap Eclipse™ Tribrid™
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Sciex Triple Quad™ 7500
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PE NexION 2000
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MESO Sector S 600MM
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Molecular Devices SpectraMax M5e
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BD LSRFortessa™ X-20
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QIAcube HT
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QuantStudio™ 7 Flex Real-Time PCR System
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QIAgility
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Apricot Designs Dual Arm
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High-throughput intelligent delivery system
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FAQs
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What is the typical turnaround time (TAT) for a bioanalysis project?
The TAT for a DMPK bioanalysis project is the process from receiving the samples to uploading the analysis data. Generally speaking, the cycle for routine in vivo screening is 24-48 hours, and the cycle for in vitro screening is 24 hours. However, the specific TAT will be evaluated and appropriately adjusted by our analysis experts based on the actual situation.
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What are LOD, LLOQ, and ULOQ?
LOD, LLOQ, and ULOQ are important parameters for ensuring the reliability of bioanalytical results, defined as follows:
LOD (Limit of Detection) refers to the lowest amount or concentration of analytes that can be reliably detected under certain analysis conditions but not necessarily for accurate quantification.
LLOQ (Lower Limit of Quantification) is the lowest concentration of analyte in a sample that can be reliably quantified with acceptable accuracy. The LLOQ is the lowest concentration point of the standard curve and should be suitable for the anticipated concentration and experiment purpose.
ULOQ (Upper Limit of Quantification) is the highest concentration of analyte in a sample that can be reliably quantified with acceptable accuracy under given analysis conditions and methods. The ULOQ is the highest concentration point of the standard curve and should be suitable for the anticipated concentration and experiment purpose.
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What is method validation?
Method validation is a series of tests and evaluations to demonstrate the reliability of a specific analytical method in determining the concentration of an analyte in a certain biological matrix, aiming to prove that the adopted bioanalytical method is suitable for the intended purpose. Generally, the complete method validation of a chromatographic analysis should include selectivity, specificity, matrix effect, calibration curve (response function), range (from LLOQ to ULOQ), accuracy, precision, carryover, dilution linearity, stability, and reproducibility of sample re-injection, etc.
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What are the advantages of conducting Non-GLP bioanalysis?
The advantage of Non-GLP bioanalysis is that it provides greater flexibility, allowing researchers to make necessary optimizations and adjustments during the experiment. Additionally, its relatively lower cost increases the cost-effectiveness of the research. Most importantly, Non-GLP bioanalysis can obtain experimental data quickly with a shorter turnaround time, thereby accelerating the research process.
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