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Bioanalysis

Bioanalysis has become an indispensable part of new drug research. Bioanalysis can accurately determine the concentrations of target analytes in biological matrices, providing data support for drug safety and efficacy.
Services
  • 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.
Novel Drug Modalities
  •   Method Development and Analysis for Compounds with Low Sensitivity.

Including endogenous hormone assays such as: Testosterone, Progesterone, Vitamin D, etc.

  •   Analysis of Unbound (Free) Drug Fraction.

Examples: Unbound drug analysis for albumin-conjugated drugs, unbound drug analysis for liposomal drugs, etc.

  •  Application of Derivatization Techniques.

Examples: Analysis using derivatization methods for Methimazole, analysis using derivatization methods for Mycophenolic Acid, etc.

  •  Concentration Analysis of Labile Compounds.

Example: Statins, etc.



Small Molecules
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.
Overview
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.

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.
FAQs
What are LOD, LLOQ, and ULOQ?     
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.
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.
What are the advantages of conducting Non-GLP bioanalysis?