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
Kinetic Solubility in PBS, SGF, SIF
Thermodynamic Solubility in PBS, SGF, SIF
Chemical stability in PBS, SGF, SIF
Log D7.4
Microsomal stability; Plasma stability
Whole blood stability
Hepatocyte stability
S9 stability; UGT activity
Aldehyde Oxidase (AO)
Reaction Phenotyping
Microsomal protein binding
Plasma protein binding
Brain protein binding
Blood-to-plasma partition
MDCK and Caco-2 permeability
P-gp substrate identification
P-gp inhibition
hBCRP substrate identification
CYP inhibition (%inhibition) & IC50
Enzyme assay
Melanin binding
GSH reactivity
Other customized assays
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)
mouse, rat, dog and formulation screening
Exogenous and endogenous compounds
Mouse rat and monkey
ADA and Nab detection
CRS,FACS and RO analyses
Targeted omics assays
FACS analysis
Biomarker and Pretox studies
BBB penetration: Brain, CSF, Kp,uu;
Liver, kidney, lung etc for distribution;
Excretion: fecal, bile and urine
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.
RA、EAE、SLE、IBD、AD
GVHD and asthma models;
Cytokine, HE, and IHC detection.
IVIS system for metastatic and inflammation analyses;
Metabolic and NASH disease models;
Co-development and customized services
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
Experimental Animals:
Balb/c, 6-8 weeks, female
Modeling reagent:
Oxazolone (OXA)
Modeling method:
Sensitization: day 0 on back
Rechallenge: day7-21, 7 times
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
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