Discovery Biology Services
Pharmacology & DMPK


Viva Biotech conducts research on various test compounds utilizing both its in vivo pharmacology, in vitro ADME testing platform and in vivo PK testing platform. This allows us to gather basic pharmacokinetic parameters of drugs, as well as study the properties and characteristics of their absorption, distribution, metabolism, and excretion (ADME). Our high-quality data caters to the requirements of various stages in the development of new drugs and has received widespread recognition from both domestic and foreign customers.




Reasons for failure of new drug development

(Images from:《Drug Safety Sciences and the Bottleneck in Drug Development》)



Laboratories Equipped With Bioanalytical Instruments and Equipment


Sciex7500+ Triple quadrupole

Sciex 6500+ Triple quadrupole

Sciex 5500 Qtrap

• Agilent 1290 Infinity II

• Water I-Class Premier

• WinNonlin 8.3

• 96-well Micro-Equilibrium Dialysis HTD

• Millicell ERS-2 Voltohmmeter

• Quintix® Semi Micro Balance

• Deep Freezers

• Centrifuges (low temperature)

• Homogenizer (low temperature)

• Apricot 52-Pipette Liquid Handling

• Animal Lab


Liquid chromatography mass spectrometer


ADME Analysis, PK Profiling and Efficacy Evaluation
In Vitro ADME
  • Physicochemical Properties

    Kinetic Solubility in PBS, SGF, SIF

    Thermodynamic Solubility in PBS, SGF, SIF

    Chemical stability in PBS, SGF, SIF

    Log D7.4

  • Metabolic Stability

    Microsomal stability; Plasma stability

    Whole blood stability

    Hepatocyte stability

    S9 stability; UGT activity

    Aldehyde Oxidase (AO)

    Reaction Phenotyping

  • Distribution

    Microsomal protein binding

    Plasma protein binding

    Brain protein binding

    Blood-to-plasma partition

  • Permeability and Transporter

    MDCK and Caco-2 permeability

    P-gp substrate identification

    P-gp inhibition

    hBCRP substrate identification

  • DDI

    CYP inhibition (%inhibition) & IC50

  • Exploratory Assays

    Enzyme assay

    Melanin binding

    GSH reactivity

    Other customized assays

  • Metabolite profiling and
    identification-related services (Collaboration with XenoFinder)

    Metabolic soft sport analysis in liver microsomes, reactive metabolite screening in liver microsomes, S9 lysosomes, and hepatocytes

    CYP enzyme and Aldehyde oxidase phenotyping (analysis of the metabolite formation)

    Metabolite profiling in animal plasma and tissues

    Study in rodents, dog, and monkey (metabolite profiling in plasma, urine, bile, and/or feces)

PK for Small Molecule and Antibody
  • Discrete and cassette dosing

    mouse, rat, dog and formulation screening

    Bioanalysis Services

    Exogenous and endogenous compounds

  • Antibody PK and Profiling

    Mouse rat and monkey

    ADA and Nab detection

    CRS,FACS and RO analyses

  • Bioanalysis Services

    Targeted omics assays

    FACS analysis

    Biomarker and Pretox studies

  • Distribution, Excretion

    BBB penetration: Brain, CSF, Kp,uu;

    Liver, kidney, lung etc for distribution;

    Excretion: fecal, bile and urine

Efficacy Study(tumor, autoimmune, inflammation, metabolic and other diseases)
  • Syngeneic and CDX models

    30 + syngeneic models evaluated;

    Expanded tumor drug evaluation: leukemia, breast, lung, melanoma, prostate cancer,  and metastatic models.

  • Antibody PK Profiling

    Immune Cell and TIL Analyses for mouse rat and monkey;

    Antibody PK, distribution and pre-tox studies;

    CRS,FACS and RO assays.

  • Autoimmune diseases

    RA、EAE、SLE、IBD、AD

    GVHD and asthma models;

    Cytokine, HE, and IHC detection.

  • Other models

    IVIS system for metastatic and inflammation analyses;

    Metabolic and NASH disease models;

    Co-development and customized services

Case Study
Tumor Growth Inhibition with Drug Treatment


Group TGI(%)
PBS 0
Oxaliplatin 38.78
Paclitaxel 57.92
5-Fluorouracil 4.23
Cisplatin 54.84
Rivoceranib 47.14

Results


Oxaliplatin, Paclitacel, Cisplatin, 5-Fluorouracil and Rivoceranib are administered IP

No abnormal changes in body weight were observed during treatment. Data are presented as Mean±SEM;

All small molecules showed significant therapeutic effect in this model except 5-FU



Oxazolone-induced Atopic Dermatitis Model

Experimental Animals:
Balb/c, 6-8 weeks, female

Modeling reagent:
Oxazolone (OXA)

Modeling method:
Sensitization: day 0 on back
Rechallenge: day7-21, 7 times




Validated Antibody PK and ADA Profiling


Parameter Unit AB-1 AB-2
Cmax ug/ml 191 134
Tmax h 115 35.2
AUC 0-t ug/ml*h 46500 12600
t1/2 h 126 56.6
MRT 0-inf_obs h 233 80.2

Validated PK methodologies (ELISA, MSD, CBA):
Fc, Fab, TCR, ADC, His, cytokine, and VHH methods for PK profiling and ADA
Multiple PK parameter analyses with PK WinNonlin software
Validated platform for mouse and monkey PK studies, and pre-tox studies

×