New Jersey
Nanjing
Suzhou
Wuhan
Tianjin
Shanghai
107 Morgan Lane
Plainsboro
NJ 08536 U.S.A.
1 Hengfei Road
Economic & Technological
Development Zone
Nanjing 210038 China
1318 Wuzhong Avenue
Wuzhong District
Suzhou 215104 China
666 GaoXin Road,
Wuhan East Lake
Hi-tech Development Zone
Hubei 430075 China
111 Huanghai Road
Tianjin Economic-Technological
Development Area (TEDA)
Tianjin 300457 China
288 Fute Zhong Road
Waigaoqiao Free Trade Zone
Shanghai 200131 China
Fully Integrated Solutions
Contact us
ltd.wuxiapptec.com
Shanghai
Tel: +86(21) 5046 5122
Fax: +86(21) 5046 1000
Email: info_ltd@wuxiapptec.com
U.S./Europe
Tel: +1(609) 799 2295
Fax: +1(609) 799 7497
Email: info_ltd@wuxiapptec.com
LTD201508B2
WuXi AppTec Laboratory Testing Division
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Laboratory Testing Division
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Laboratory Testing Division
Laboratory Testing Division
Global Compliance
2008
As a key business within WuXi AppTec’s diversified portfolio,
"We provide a world class, fully integrated testing solution
the Laboratory Testing Division (LTD) is comprised of seven
enabling scientists to transform their ideas into the best
business units (BUs), over 2,000 employees and operations in
healthcare products, moving science from research bench to
Shanghai, Suzhou, Tianjin, Wuhan, Nanjing and New Jersey.
hospital bed, in order to better serve our community.
•Biological Animal Facility Received AAALAC Accreditation
LTD's integrated services and solutions in pharmaceutical
development span from early screening to preclinical
We serve as a healthcare 'Silk Road', which enables advanced
development and into clinical sample analysis. Leveraging
technologies to enter the Chinese market effectively, by
other established WuXi businesses in MedChem, synthesis
leveraging our deep regulatory expertise and w ide reaching
and formulation, LTD is well positioned to enable customers
sales and marketing network."
to accelerate their discovery processes and empower them to
bring new, innovative medicines to patients.
Jason Liu
2009
•Analytical Laboratory Passed MPA Inspection
•Bioanalytical Laboratory Passed FDA Inspection
2010
Jason Liu, PhD
SVP & COO, Laboratory Testing Division
• Toxicological Animal Facility Received AAALAC Accreditation
• Toxicological Laboratory Received GLP Certificate from CFDA
2011
ASU
MD
BAS
BIO
• Biological hERG Laboratory Received GLP Certificate
from OECD
• Analytical Laboratory Passed FDA Inspection
• Biological Animal Facility Passed AAALAC Inspection
• Analytical Laboratory Passed CFDA Inspection
• Biological Animal Facility Passed AAALAC Inspection
• Analytical Laboratory Passed CFDA Inspection
• Toxicological Laboratory Received GLP Certificate
from OECD
IMMU
2012
• Toxicological Laboratory Passed CFDA Inspection
2013
ONCO
• Toxicological Laboratory Passed FDA Inspection
• Toxicological Laboratory Passed OECD Inspection
2014
2015
DMPK
• Analytical Laboratory Passed MPA Inspection
TOX
• Analytical Laboratory Passed CFDA Inspection
• Biological Laboratory Passed OECD Inspection
• Toxicological Animal Facility Received
“Exemplary” Commendation from AAALAC
• Analytical Laboratory Passed CFDA Inspection
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Laboratory Testing Division
Discovery
Screening
Lead
Optimization
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Candidate
Nomination
Laboratory Testing Division
Clinical
Preclinical
Market
CMC
ASU (Drug Substance and Drug Product)
• Method development & validation
• Compound characterization & batch release
• Stability study
• Regulatory CMC
Hit-to-Lead
BIO/ONCO/IMMU
• In vitro efficacy
• In vivo target engagement
• In vivo pharmacology
DMPK
• HTS/MTS
• Physicochemical property
measurement
• Permeability
• Stability in biological
solutions
• Metabolic stability
CSU
• Synthetic chemistry
BAS
• Clinical chemistry
• Immunogenicity
• Large/small molecule
bioanalysis (GLP-like/
GLP)
ASU
• Analytical chemistry
• Chiral SFC separation
• Natural product extraction,
isolation and identification
STA (Drug Substance)
• Process development
• GMP API manufacturing
Discovery
Package
IND/NDA
Package
Discovery Screening
Safety
Preclinical
Lead Optimization
Clinical
Candidate
Nomination
Market
Clinical
DMPK
• PK
• Permeability
• Drug-drug interactions
• Metabolite ID
ASU
• Analytical chemistry
• Chiral SFC separation
(scale-up)
Market
BIO/ONCO/IMMU
• In vitro selectivity asssay
• MOA
• Early cellular toxicity assay
• In vivo target engagement
• In vivo pharmacology
CSU
• Compound synthesis/MedChem
BAS
• Biomarker analysis (soluble, cell,
tissue, genetic)
• Large/small molecule bioanalysis
(GLP-like/GLP)
Medical
Device Testing
BAS
• Clinical chemistry
• Immunogenicity
• Small/large molecure
bioanalysis
ADME
Preclinical
TOX
• Early diagnosis testing
• Mini Ames
TOX
• General toxicology
• Genetic toxicology
• Safety pharmacology
• Reproductive toxicology
BIO/ONCO/IMMU
• hERG assays
Device
Package
Lead Optimization
PDS (Drug Product)
• Preformulation
• Formulation
development
• Clinical trial material
manufacturing
Pharmacology
BIO/ONCO/IMMU
• Ligand binding
• Receptor profiling
• In vitro efficacy
• In vivo efficay (PD)
• MOA
• Translational medicine
DMPK
• Permeability
• Plasma protein binding
• RBC partitioning
• DDI (CYP inhibition, induction, phenotyping)
• Transporter profiling
• Metabolite ID (in vitro/in vivo)
• PK/bioavailability
• Allometric scaling
• Radiolabeled and unlabeled mass balance and tissue
distribution
• QWBA and QTD
• Route of elimination
BAS
• Biomarker analysis (soluble, cell, tissue, genetic)
• Small/large molecule bioanalysis (GLP-like/GLP)
Laboratory Testing Division
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Laboratory Testing Division
Analytical Development from Early to Late Phases
•Method development and validation for APIs and drug
products
•GMP/GLP release of early phase APIs
•GMP release of late phase and commercial APIs and drug
products
•Drug product manufacturing support
•Impurity/degradation characterization
Stability Studies
•For small molecule drugs and large molecule products
•API and clinical trial material (CTM) stability studies for
IND/NDA/ANDA
•Primary and registration stability studies (formal) as well
as accelerated and long-term stability studies
•Commercial stability study
•Dedicated sample management, lab testing and
documentation
WuXi Separation Center
•Chiral and achiral separation by SFC and HPLC
•Research & development or GMP mode
•From small (mg) to large (hundreds of kg) scale
Center of Natural Products
•Expansive natural product library with diverse structures
•Extraction, isolation and identification of natural products
Impurity Isolation and Identification
Analytical Service Unit
•Isolation and identification of impurity/degradation
products
Regulatory CMC
End-to-end analytical service provider from discovery to commercialization
One of the largest stability storage and testing facilities in the world
•For global and China submission
•Full CMC package by dedicated technical writing group
The largest chiral and achiral separation facility in China
Physicochemical Characterization & Excipient Release
FDA, CFDA & MPA-compliant
•Solubility, logP/logD and pKa
•Heavy metal by ICP-MS
•HRMS, NMR (1D/2D), LCMS, GCMS, IR and UV
•ROI, DSC, TGA, DVS, XRPD, PLM, elemental analysis
•Refractive index (RI), conductivity, viscosity, optical
rotation, turbidity, specific gravity, bulk density etc . . .
Laboratory Testing Division
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Laboratory Testing Division
In Vitro Screening Platform
•Assay development and transfer
•Kinase, GPCR, transporter and ion channel panels
•Capable of radioactive assays involving: 3H, 14C, 32P,
33
P, 35S & 125I
Infectious Disease and Immunology
• In vitro and in vivo antiviral/antibacterial platforms
•Clinical study support
•Vaccine & biologics services
• In vitro and ex vivo immunology assays
• In vivo immunology animal models
Central Nervous System and Pain
• In vitro and in vivo pharmacology
•Ion channel assays
• In vivo electrophysiology
•Receptor occupancy
• In vivo disease models
Cardiovascular and Metabolic Disorders
•Regular (monthly) supply of DIO mice
•Pharmacology of obesity, diabetes, dyslipidemia
and thrombosis
•Telemetry hypertension and angina pharmacology
Early Stage Safety Assessment
•GLP and non-GLP hERG assays
•Cardiac safety panel screening assays
•CNS safety behavioral models
Biology
AAALAC and OLWA-certified animal facility, OECD-certified GLP
electrophysiology lab, CLIA-compliant molecular testing lab
A leading biological CRO in infectious disease, CNS and pain,
immunology and cardiovascular and metabolic diseases
•Cardiomyocyte action potential measurement
•Purkinje fiber action potential measurement
•Guinea pig MAP
•Telemetry measurements of ECG and blood
pressure
Structural Biology and Modeling
•Protein expression, purification and crystallization
•Off-the-shelf protein crystallization
•Crystal structure determination
•Fragment-based drug discovery (FBDD)
Fully integrated with MedChem programs delivering over 20
preclinical drug candidates since 2008
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Laboratory Testing Division
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Laboratory Testing Division
CRISPR
•Generation of cell lines and mouse models with
knockout and knockin mutations
•Genome-wide knockout screening for target ID
(human and mouse cell lines)
Oncology
AAALAC and OLWA-certified animal facility
Largest collection of Asia-prevalent PDX models
IND-enabling in vivo data for CFDA & FDA filing
Genome-wide screening with CRISPR libraries
•Target validation for oncology, immuno-oncology &
rare genetic diseases
Tumor Models
•~150 cell line-derived xenograft (CDX) models
•24 bioluminescence imaging orthotopic & metastatic
tumor models
•~1000 PDX models available, 509 models molecularly
profiled and annotated, 220 models currently in life
•The world's 1st integrated tumor models database:
OncoWuXi
st
The world's 1 integrated online tumor model database
•The largest collection of PDX models of Asiaprevalent cancer types
•Drug-resistant PDX models for targeted cancer
therapeutics
http://onco.wuxiapptec.com
•~70 primary cancer cell lines derived from PDX
models
Cancer Immunotherapy
•~50 syngeneic tumor models
•TIL, Treg and cytokine focused immunoassays
•T-cell /cancer cell mechanistic and functional assays
•Validated with PD-1/PD-L1 antibody
Translational Science
•Tissue bank with over 2,500 human tumor samples
•Patient selection biomarker discovery by NGS using
Illumina HiSeq X10
•Simulated Phase II-like trials with PDX panels
•Focal radiation, standard of care & combination
therapy
•MOA based PD assays
Tumor Cell Biology
•Biochemical assays
•Cell-based mechanistic and phenotypic assays
•Tumor cell chemo-sensitivity assays
•Cancer stem cell (CSC) platform
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Laboratory Testing Division
Autoimmune diseases and inflammatory animal models
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Cancer Immunology Platform
Biomarker Service
•TM (tumor microenvironment) analysis for
•Tissue-based biomarkers – pathology lab
•Rheumatoid arthritis (RA) models
•Inflammatory bowel disease (IBD) model
•Multiple sclerosis (MS) models
•Gout models
•Delayed type hypersensitivity (DTH) models
•LPS-induced airway inflammation in Wistar rats
•Lymphoid tissue and peripheral blood analysis
•Psoriasis model
•ConA-induced cytokine model in mice and rats
•Lymphocyte activation / functions
immunoscore by FACS, IHC and IF
•Cytokine and Chemokine analysis
•Adoptive T cell therapy
Immunology Center
AAALAC-accredited SPF animal facility
CLIA certification and GCP-compliance
Partnerships with world-renowned pathology laboratories
Histopathology core equipped with automated high throughput systems
Advanced flow cytometry core with 18-color analysis and sorting capability
Laboratory Testing Division
•Cell-based biomarkers – flow cytometry lab
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Laboratory Testing Division
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Laboratory Testing Division
Early and Definitive In Vitro ADME
DMPK
•Physicochemical characterization
•Permeability
•Metabolism and clearance
•CYP inhibition/induction/phenotyping
AAALAC, FDA and CFDA-inspected
A comprehensive ADME and PK service provider from HTS through IND filing
Integrated with Biology and MedChem for streamlined lead optimization
•Plasma protein binding and RBC partitioning
•Transporter drug-drug interactions
•Metabolite identification
Early and Definitive In Vivo PK
•All major animals from mouse to cynomolgus monkey
Delivered 12 preclinical drug candidates in 2014
•Metabolite identification and quantitation
•Full PK profiling and modeling for all species
•Intravenous, oral gavage, intramuscular, subcutaneous,
intraperitoneal, transdermal, duodenal, intranasal
instillation, intrathacheal instillation and sublingual
dosing
•Blood, plasma, urine, feces, bile, CSF, lymph and tissue
sampling
• 14C-labeled mass balance: route of excretion, tissue
distribution
•A variety of common & customizable surgical models
•QWBA (quantitative whole-body autoradiography) and
QTD (quantitative tissue dissection)
Laboratory Testing Division
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Laboratory Testing Division
Small Molecule Drug Analysis
•Assay development, validation and sample analysis using LCMS/MS
Large Molecule Drug Analysis
•Assay development, validation and sample analysis for drug
PK, ADA and Nab assays using immunochemistry techniques
Large Molecule Assay Reagent Development
•Drug-specific mAb and pAb generation, purification, labeling
and characterization
Biosimilar Studies
•Free-to-use methods for the top biosimilars
Biomarker Analysis
•Assay development, validation and sample analysis for
soluble, cell and tissue biomarkers
Central Lab Services
•Safety testing, clinical trial supply, sample logistics and
storage for clinical trials
Bioanalytical Services
The largest bioanalytical lab in Asia for biologics
The only bioanalytical lab in China inspected by the FDA, EMA, OECD and CFDA In-house, custom reagents for large molecule assays
Ultrasensitive pg/mL LLOQs in small molecule LC-MS/MS
Synthesis of stable labeled internal standards or PI/PII metabolites
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Laboratory Testing Division
General Toxicology
Safety Pharmacology
•Early diagnosis testing (EDT)
•CNS (rodent and non-rodent)
•Dose-ranging or MTD studies
•Respiration (rodent and non-rodent)
•Single dose (acute toxicity)
•Implanted cardiovascular telemetry (dog, NHP,
•Repeat dose (subacute, subchronic and chronic)
minipig)
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Laboratory Testing Division
Medical Device
•Non-invasive DSI JET assessments for biologics
Developmental and Reproductive Toxicology
•Dose-ranging study on embryo-fetus development
in rats, rabbits
•Fully validated DSI Ponemah system for data
collection and analysis
•hERG assay via manual patch clamp (Biology)
•Definitive study on embryo-fetus development in
rats, rabbits with TK (Seg II)
•Study on fertility and early development to
implantation in rats (Seg I)
Immunotoxicology
•Tissue cross reactivity (human tissues)
•Immunogenicity/ADA
•Immunophenotyping
Genetic Toxicology
•T-cell-dependent antibody responses (TDAR)
•Ames assay
•Chromosomal aberration assay (CHO-WBL cell and
human lymphocyte)
Anatomic and Clinical Pathology
•Toxicological or immunopathology
•Micronucleus assay (rat and mouse)
•Micronucleus assay (CHO-WBL cell)
Toxicology
AAALAC, FDA, OECD and CFDA-inspected
A premier toxicology service provider in China
The 1st CRO in China with an ACLAM-certified veterinarian
Comprehensive toxicology packages supporting China and
global IND/NDA filings
Biosafety Assessment & Biocompatibility Test
Global Regulatory Consulting
•Annex A ISO-10993-1
•Global regulatory assessment & strategy development
»»Tests for cytotoxicity
•Pre-market submission: 510(k), PMA, CFDA, CE Mark
»»Tests for genotoxicity
•Quality System (QSR & ISO)
»»Tests for hemocompatability
»»Tests for implantation
»»Tests for sensitization
»»Tests for irritation or intracutaneous reactivity
»»Tests for pyrogenicity
»»Tests for systemic toxicity (acute)
»»Test for subacute and subchronic toxicity