Pharmacology & DMPK - Discovery Biology Services - CRO Services

Viva Pharmacology team has years of experience and well-trained experts in a wide variety of platforms and technologies, offering services for DMPK, efficacy study in vitro and in vivo, ranging from assay development for both small molecule and antibody, comprehensive biologics screening, characterization and optimization for drug candidates to DMPK service, efficacy evaluation, pre-tox study and lead preclinical candidate (PCC).

The senior scientists provide the full-spectrum of in vitro and in vivo characterization services including efficacy evaluation of compound, therapeutic monoclonal antibody, bsAb, ADC, CAR-T, and other large molecules for the better treatment of tumor disease, autoimmune condition, inflammatory indication, metabolic disease, diabetes and others.

We also provide high-quality preclinical PK in 5 species, safety, exploratory toxicology, mechanism and biomarker study in vitro and ex vivo to support programs of biotech and pharmaceuticals worldwide.

Capabilities in Small
Molecules & DMPK
Capabilities in Antibody
Analyses and PK Profiling
Capabilities in
Immuno-Assay in vitro
Capabilities in Tumor
Efficacy Evaluation
Capabilities in Autoimmune and
Inflammation Platform

Capabilities in Small Molecules & DMPK

Analytical Support and ADME Capability

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Team

Senior management team

Experienced scientists with

high quality delivery

Facility

Analysis assay lab

Animal facility for mouse, rat and rabbit

Collaborations with academic and partners

Instrument

Mass spectrum:

Sciex 5500 Qtrap

Sciex 6500+ Triple quadrupole

Sciex7500+ Triple quadrupole

Experience and Capacity

>6000 tests of in vitro ADME assays per year

>400 PK & BBB studies in rodents and dog per year

>50 DRF and Tox studies in rodents per year

Modality including compounds, peptides, Protac, molecular glue, and ADC

Served >50 clients per year

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, Plasma stability
Whole blood, Hepatocyte stability
S9 stability; UGT activity

Distribution

Microsomal protein binding
Plasma protein binding
Brain protein binding
Blood-to-plasma partition

Permeability and Transporter

Caco-2 permeability
MDCK permeability
P-gp substrate identification
P-gp inhibition
hBCRP substrate identification

Drug-Drug interaction(DDI)

CYP inhibition (%inhibition) & IC50
TDI

Exploratory Assays

Enzyme assay
Melanin binding
GSH reactivity
Other customized assays

In Vivo PK

PK and tox studies

Discrete dosing in mouse, rat, dog, monkey
Cassette dosing (5 in 1) in mouse or rat
Dosing formulation screening
Acute/Chronic Tox and DRF study

Distribution, Excretion

BBB penetration: Brain, CSF, Kp, uu;
Liver, kidney, lung etc for distribution;
Excretion: fecal, urine

Bioanalysis Services

Exogenous compounds
Endogenous compounds
Peptides, protacs, ADCs

Capabilities in Antibody Analyses and PK Profiling

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Detection: Fc, Fab, ADC, TAG, cytokine, and VHH
Species: Mouse, Monkey, Rat and human
Data analysis with WinNonlin, interpretation and trouble shooting
MDCK-hFcRn transcytosis for PK assay in vitro
Application: IgG, Fc fusion protein, Fc mutation, ADC, and YTE etc.
AH50/CH50 hemolysis complement assay
Anti-ds DNA Ab detect
Receptor Occupy assay in mouse, rat, and monkey
ADA & Nab detections with standardized methods
Multiple assay platform: ELISA, MSD, FACS, FRET, qPCR and HTRF

Capabilities in Immuno-Assay in vitro

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Lymphocyte purification/activation

T cell activation

Anti-CD3/ CD28, MLR, and Super antigen stimulations

Immune checkpoint assays

Proliferation/ cytokine assays

T cell polarization

Th0 cell purification

Th1 and Th2 polarization

Th17 and Treg differentiation

T cell mediated cytotoxicity

BsAb and TCE
Differentiation

NK cell function

BM: IFN-γ, CD107a, NK1.1

Purification and proliferation

NK cell activation (IL-2)

Tumor killing by co-culture

DC and Macrophage

Immature/Mature DC

M1/M2 macrophage

Signal pathway

p-STAT phosphorylation

Phospho-Kinase array

Transcription factor

Protein / mRNA expression
Functional assay

Cytokine

Cytokines in serum/section

Intracellular/Extracellular

MSD, CBA, single/multi-plex

Mouse, rat, monkey, human

Antibody related cytotoxicity

ADCC and ADCP

CDC and Hemolysis

Mouse, monkey, human or other species

Bio assays

IC50 and receptor occupancy

Drug resistant assays

Adhesion assays

Assay platform: FACS (up to 13 colors), FACS sorting, ELISA (single-plex), CBA (Cytometric Bead Array, multi-plex), Proliferation (CTG, CFSE labeling, Ki67), Killing (CTG, LDH, CFSE labeling), HTRF, AlphaLISA, Incucyte and IVIS

Capabilities in Tumor Efficacy Evaluation

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Syngeneic

20+Models establishment and available for evaluation

Variety of efficacy evaluation cases
CDX

50+ models

All types established for clients

Available (Nude, SCID NOG and NSG)

Humanized SCID and NSG
IVIS

Metastasis

Various Luc-cell in house

Radiation models

GvHD models and transplant

Pharmacodynamics for immuno-oncology, syngeneic and CDX models
Reliable and reproducible results with high quality
Studies ex vivo for TIL, PD, Biomarker, TAA, IHC, hematology and blood chemistry

Capabilities in Autoimmune and Inflammation Platform

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Autoimmune Disease Models

Experimental Autoimmune Encephalomyelitis (EAE)

MOG, MBP, PLP_139-151-induced model in mice or rats

Rheumatoid Arthritis (RA)

CIA, CAIA , AIA model in mice or rats

Systemic Lupus Erythematosus (SLE)

Pristane-induced, MRL/lpr mice lupus model

Inflammatory Bowel Disease (IBD)

DSS, TNBS, CD4⁺CD45RB^high T cell-induced model
Allergic Disease Models

Atopic Dermatitis (AD)

Oxazolone, MC903, DNCB, FITC-induced model in mice or rats

Psoriasis

IMQ, IL-23-induced model in mice or rats

Asthma

OVA, HDM-induced model in mice
Short Term Inflammation Models

LPS-induced Acute Inflammation

APAP-induced Acute Liver Injury

KLH-induced T cell Dependent Antibody Response (TDAR)

OVA-induced Eosinophilic Gastroenteritis (EG)

Air Pouch Model
Fibrosis Models

Liver, Pulmonary, Kidney Fibrosis

CCl₄, DMN, TAA-induced liver fibrosis in mice and rats

Bleomycin-induced pulmonary fibrosis in mice

Folic acid-induced kidney fibrosis in mice
GvHD Models

GvHD induced by X-ray irradiation in mice

GvHD without irradiation in rats