Bioanalysis

Bioanalysis services relying on HitGen's one-stop service platform for drug development, cover all stages from drug screening to PCC determination, including bioanalysis in pharmacokinetics, pharmacodynamics and toxicology.

Major technical services and platforms

We have developed ADME and DMPK evaluations for a variety of small molecule chemicals, PROTAC protein degradation targeting chimeras, oligonucleotides (ASO, siRNA, Aptamer, miRNA) and their delivery modifications including peptide, Gal-Nac, C16, C6, LNP, LA, EPA, DHA delivery modifications, and antibody-drug conjugate (ADC) drugs.

• In vitro ADME

•    In vivo PK

Commonly used species: mice and rats

Common tissue and matrix include whole blood, plasma, serum, brain, cerebrospinal fluid, urine, feces, liver, gastrointestinal tissue or other tissue.

In vivo PK service

 Solvent and formulation screening

 Tissue distribution

 Bioavailability

 In vivo identification of metabolites

 PK/PD

 Tissue distribution/ Blood-brain barrier permeability Kp,uu

•    In vivo TK

 TK/PD/TOX analysis

 Sex difference

 Dose-Response Relationship

 Accumulation analysis

 Active ingredient detection

 Prodrug detection

 Metabolite detection

 Metabolite detection in TK samples

 Immunogenicity assessment

•    Identification of drug metabolites

Provides metabolite analysis and structural identification services for the analysis, isolation and identification of metabolites in biological matrices to support drug discovery and safety research. Research services range from optimal selection of lead compounds to the drug discovery phase.

 Metabolic soft point analysis

 Screening of (glutathione or cysteine)-trapped reactive metabolites

 Identification of liver microsomal metabolites

 Identification of hepatocyte metabolites

 Identification of S9 metabolites

 Identification of metabolites in plasma or whole blood in vitro

 Identification of metabolites in rats and mice

 Safety evaluation of metabolites

 Tissue distribution (plasma, serum, liver, kidney, lung, brain, heart, spleen, muscle, skin, lymph, etc.)

 Excretion /Identification of metabolites in vivo

Bioanalysis platform

•    Small molecule drug research

PK/PD/TK study

 In vitro ADME

 In vivo PK/TK

 Identification of metabolites

 In vivo tissue distribution

•    Small nucleic acid drug research

PK, TK, immunogenicity assessment, Cytokine & Biomarker in PD or TOX

 In vitro evaluation of on-target/off-target effects

 Stability in serum, lysosome, S9

 Immunogenicity of PBMC

 Evaluation of primary hepatocyte delivery/activity

 In vivo tissue distribution

 In vitro identification of metabolites

•   LC-MS/MS/HRMS platform

High throughput sample tissue manager pre-system, high sensitivity and high-resolution mass spectrometry platform. The platform is equipped with multiple UPLC-DAD, UPLC-UV, UHPLC-FLD, LC-MS, LC-MS/MS and Qtof instruments and technologies, which can be used in development, validation and transfer of analytical methods in the Non-GLP analysis stage according to customer requirements.

Platform advantages

• Rapid pharmacokinetic screening of multi-compounds in cassette PK

• Multiple species: mice, rats

• Multiple routes of administration: oral, intravenous injection, intraperitoneal injection, subcutaneous injection, etc.

• Provide important PK parameters: half-life, area under the drug time curve, Cmax, etc.

• Economizing compounds: About 1 mg of compounds can be evaluated