Non-GLP Bioanalysis

Non-GLP Bioanalysis

Platform Introduction

It is necessary to study a drug mechanism and evaluate its efficacy to achieve safe, rational, and effective drug use in the drug development process. This evaluation includes pharmacokinetics, pharmacodynamics, and toxicology. An effective analytical methodology is required to monitor drugs, their metabolites, and changes in biomarkers to qualitatively and quantitatively elucidate the drug transformation process and changes in the body under the influence of drugs. Bioanalysis is an effective detection method that accurately determines the concentrations of drugs, metabolites, and biomarkers in biological matrices (such as serum, plasma, urine, cells, and various tissues). Bioanalysis can provide safety and efficacy data for drugs, help researchers accurately evaluate the experimental results of pharmacology, pharmacokinetics, toxicokinetics, and bioequivalence, and make critical decisions. Bioanalysis has become an indispensable part of new drug research.

Our Non-GLP Bioanalysis Platform

Since 2006, we have focused on preclinical bioanalytical services and 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, pharmacodynamics, and toxicology. We provide high-quality customized services for the personalized needs of customers in large and small molecule drugs, biomarkers, immunogenicity, and cell-based assays.

In vitro
sample bioanalysis

We support ADME in vitro experiments with various high throughput autosamplers such as ADDA (Apricot Designs Dual Arms). The analytical speed is as fast as 12 seconds/sample.

In vivo
sample bioanalysis

We have considerable experience in the bioanalysis of conventional small molecule chemical drugs. We developed bioanalytical solutions for other types of molecules, including polar compounds, unstable compounds, chiral compounds, biomarkers, Proteolysis-Targeting Chimeras(PROTACs), peptides, proteins, nucleoside triphosphates, and oligonucleotides. We have also established bioanalytical solutions for special dosing methods such as liposomes, PEGylated drugs, and antibody-drug conjugates (ADCs).

Special matrices and microsampling analysis

We have developed bioanalytical methods for samples obtained from more than 70 biological matrices and special sample collection methods. Sample pretreatment and bioanalysis methods have been established for matrices such as cerebrospinal fluid, microdialysate, PBMC, and ophthalmic tissues with limited sample volume and demanding lower limit of quantification (LLOQ) requirements. We have a complete set of procedures from sample collection to bioanalysis for special sample collection methods such as dry blood spot, dry plasma spot, capillary sampling, and volumetric absorptive microsampling (VAMS).

Instrument platform

The qualitative and quantitative bioanalysis of drug candidates, metabolites, biomarkers, and large molecule anti-drug antibodies in in vivo and in vitro samples is achieved through industry-leading liquid chromatography mass spectrometry (LC-MS) analysis platform, ligand binding assay (LBA) platform, and related technologies to support the research and optimization of drugs and formulations.

We provide customers with high-quality data on millions of in vitro and in vivo samples each year based on highly optimized experimental procedures, robust high-throughput technologies, and good laboratory management systems. The comprehensive application of sample pretreatment automation and electronic notebook systems enables the visual tracking of the whole process and ensures a short bioanalysis turnaround time (TAT) for customers. For example, the TAT of a conventional small molecule screening project is less than 24 hours for in vitro bioanalysis and 48 to 72 hours for in vivo bioanalysis. In the meantime, we follow bioanalytical regulations and industry standards to ensure the robustness of analytical methods and the reliability of our data. By helping customers overcome complex technical challenges of bioanalysis and providing specialized analytical services, we strive to empower our customers to quickly develop new drugs that can change and save lives.

Key Features

Deep in technology

Each analytical technology platform has a dedicated team

Dedicated analytical teams have been established for the multiple analytical technology platforms in the preclinical drug development process, including in vitro high-throughput screening team, in vivo screening team, biomarker team, (investigational new drug) IND, and large molecule bioanalysis team. Each team constantly strives for perfection in their respective focus areas and delivers high-quality data efficiently. At the same time, our professional operation team, instrument maintenance team, report, and QC team work jointly to ensure the delivery of high-quality data and smooth progress of the projects.

Excellent in analysis

High-caliber new analytical capability building research team

We continuously monitor the development of new modalities, various cutting-edge advancements, and new bioanalytical technologies, and we have formed a dedicated bioanalytical research and development team. This team, led by ~10 Ph.D.'s from prestigious universities, has developed several high-quality bioanalysis platforms for new modalities such as peptides, proteins, and oligonucleotides. Since its inception, the team has published five papers, 26 conference posters, and two patents. The team members have won many awards, including the European Bioanalytical Forum Bioanalysis Rising Star Award, the Clinical and Pharmaceutical Solutions through Analysis Forum Excellent Young Scientist Award, and multiple customer awards.

Our Strengths

Seamless upstream and downstream transitions

Analytical method transfers between in vitro and phases and between non-GLP and GLP bioanalysis phasesOne-stop analysis

Comprehensive services

From screening to IND filingMultiple analyte types: conventional small molecules, Proteolysis-Targeting Chimeras(PROTACs), biomarkers, peptides, proteins, oligonucleotides.PK and ADA experiments for large moleculesOver 70 matrices

High-throughput and automated instrument platforms

Automated sample pretreatment systemsIndustry-leading analytical platformsHigh-throughput analytical platforms (12 sec/injection)

High-quality data for IND filing

PK and ADA experimentsFollowing IND filing criteria of NMPA, FDA, EMAZero findings through customer and regulatory audits

Experienced research staffs

> 60% hold Master's or Ph.D. degrees> 20% have more than ten years of industrial experience
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