Wu xi apptec lab testing division overview 2016

WuXi AppTec provides full services for your pharma & biopharma research & development needs

1. Mar 2016
Integrated Solutions for
Drug Development，Clinical Diagnostics
and Medical Device Testing
Laboratory Testing Division, WuXi AppTec

2. 2
Lab Testing Division (LTD) at WuXi AppTec
An Engine to Support Drug Development Initiatives
Growth Engine
Unmatched Operational
Scale
•One of Wuxi AppTec’s largest
divisions with significant
contribution to top line and cash
flow
•Strong YTY growth driven by
cutting edge businesses
•7 Major business platforms
•~1,600 employees with seasoned
leaders, proven scientific credentials
and operational expertise
•Established global operations in
both China and the U.S. with
continued momentum
•Strong financial growth fuels
continued investment in human
capital and developing our service
capabilities
•Synergistic businesses in the
preclinical and clinical stages
delivering services for PCC
nomination and IND/NDA filings
•Expansion into clinical diagnostic
and medical device testing

3. 3
Testing Solutions for Drug Development
We provide a world class, fully integrated testing solution enabling
scientists to transform their ideas into the best healthcare products,
moving science from research bench to hospital bed, in order to better
serve our community.

Our drug discovery and development service, clinical diagnostic
products and medical device testing experience will enable doctors to
better treat the patients and patients beneficial from precious
medicare.

We endeavor to transform ideas into the best healthcare products by offering integrated testing solutions

4. A Global Platform
Operation in US and China
Wuhan
ASU
Nanjing
DMPK, BAS
Tianjin
ASU
Suzhou
DMPK, BAS, TOX,
MD, Antibody Services
Shanghai (Division Headquarter)
ASU, DMPK, BAS, CDx
Plainsboro New Jersey
DMPK, BAS
LTD Site
Other WuXi Site
ASU: Analytical Service Unit
DMPK: Drug Metabolism &
Pharmacokinetics
BAS: Bioanalytical Services
TOX: Toxicology
MD: Medical Device
CDx: Clinical Diagnostics
Antibody Services
San Diego
Antibody Services

5. 5
Integrated Testing Platform
Drug Development ,Clinical Diagnostics & Medical Device Testing
•Preclinical Services
•Clinical Services
•Biosafety Assessment & Biocompatibility Test (ISO-10993-1)
•Safety consideration chemical and microbiology testing
•Regulatory consulting
•R&D on innovative clinical diagnostic instruments
•GMP IVD reagent manufacturing
Drug Development
Platform
Medical Device
Platform
In vitro Diagnostic
Platform

6. 6
Drug Development Platform

7. Synergistic Portfolio

(TOX) Toxicology
(DMPK) Drug Metabolism & Pharmacokinetics; PD Models
(ASU) Analytical Chemistry; Separation, Development & Stability
Preclinical
Candidate
Nomination
Lead
Optimization
Clinical Market
(BAS) Bioanalytical Services; Biomarker Testing
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Preclinical Services
Clinical Services
From preclinical to clinical service

8. 8
Preclinical Services
IND Enabling Service Overview
Synthesis and Formulation
• Process development
• API manufacturing
• Preformulation
• Formulation development
• Clinical trial material
manufacturing
Quality Control
• Method development & validation
• Compound characterization & batch release
• Stability studies
Regulatory CMC
Analytical Chemistry
• Clinical pathology
• Immunogenicity
• Small/Large molecule bioanalysis
Toxicology
• General toxicology
• Safety pharmacology
• Developmental and reproductive toxicology (CFDA)
• hERG safety assessment
• Genetic toxicology
In Vitro ADME
• Plasma protein binding
• DDI and transporter phenotyping
• Metabolic stability studies
• Metabolite (radio)profiling and ID
In Vivo ADME
• Single and repeat dose PK
• Mass balance (hot or cold)
• Tissue distribution (cold, QTD, QWBA)
• Metabolite (radio)profiling and ID
Bioanalysis
• Biomarker analysis (soluble, cell,
tissue, genetic)
• Small/Large molecule bioanalysis
(GLP-like/GLP)
Metabolic Disease Models and PK/PD Correlation
• Rodent disease models for obesity, diabetesCNS and dyslipidemia
• Rodent NASH models
• Nonhuman primate models for obesity, diabetes and dyslipidemia

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Preclinical Services
Track Record
CMC
• FDA, MPA, CFDA inspected
• 6 INDs to the FDA, 6 CTAs to CFDA
• 500+ early phase, 19 NDA/MAA stability programs
Safety
• AAALAC, FDA, OECD, CFDA inspected
• 125 IND/NDAs to the FDA, 114 CTA/MAAs to the CFDA
• 41 CTA/MAA packages to the EU, 2 IND/NDA packages to other agencies
ADME
• AAALAC, FDA, CFDA inspected
• 44 INDs to the FDA, 43 CTAs to the CFDA, 4 IND/CTAs to other agencies
Pharmacology
• AAALAC, FDA, CFDA inspected
• 20+ preclinical candidates (PCC), 10+ in IND stage (5 moved into phase I clinical trials, 2
entered phase II clinical trials, 1 in phase III clinical trials)

10. Clinical Services
Overview
Bioanalytical Services Supporting Clinical Studies
•Small Molecule and Biologic Quantitation
•Generic and Innovator Study Support
•Clinical PK Sample Analysis
•Radiolabeled hAME Sample Analysis
•Clinical Metabolite ID and (Radio)Profiling:
3
H and
14
C
•MIST Cross-species Metabolite Comparison
•
14
C-Labeled &
19
F-NMR Mass Balance
•Soluble, Genetic, Cellular and Tissue Biomarker Analysis
Bioanalytical Services
Safety Testing
•Chemistry
•Urinalysis
•Hematology
•Coagulation
•Immunology
•Specific Protein
•HbA1C
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Other Services
ADME Services
•CYP, Phase II enzyme and
transporter substrate phenotyping
CMC Services
•Stability Studies and Dossier Preparation
Toxicology Services
•Chronic, Subchronic Tox
•Seg I-III DART Studies
•Carcinogenicity Studies
•Juvenile Tox
•4-week batch impurity testing

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In Vitro Diagnostic Platform

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Clinical Diagnostics Services
Your Partner for Clinical Diagnostics Testing in China
•Certified clinical reference laboratory by Chinese health authority;
•End-to-end tailored solutions from genetic biomarker discovery , development to precision
medicine;
•Advanced platforms and technologies covering immunological , genetic and genomic assays.
Discipline Methodology Biomarker Tests
Molecular
Pathology
• Tissue processing (FFPE, cryo,TMAs)
• H&E
• Assay development
• IHC, ISH, FISH
• Mutation and expression analysis(PCR, RT-qPCR)
• PI3K/EGFR/RTK pathway
• Companion diagnostic (CDx) assays
Genomics
• PCR ,ddPCR and variants
• SNP Analysis
• Digital array
• FISH
• Next generation sequencing
• Viral loads and genotyping
• ADME/PGx
• Gene fusion
• Targeted exome sequencing panels

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GMP Facility Project Plan
Total 3,000 m
2
GMP facility for IVD product manufacture

2016 Q1 GMP facility location selection
2016 Q2-Q4
GMP facility installation and
commissioning
2017 Q1 GMP facility to pass validation
2017 Q2 GMP facility operational ready

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Medical Device Platform

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Medical Device
Ensuring Safe and Reliable Medical Device Products
•An extension of WuXi AppTec’s U.S. medical device experience (FDA consulting arm)
•Biosafety Assessment & Biocompatibility Test (ISO-10993-1)
•Tests for Cytotoxicity
•Tests for Genotoxicity
•Tests for Hemocompatability
•Tests for Implantation
•Tests for Sensitization
•Safety consideration associated with extractable and leachable
•Regulatory consulting
•CFDA filing for international and China customers
•Global filing for China customers

•Tests for irritation or Intracutaneous reactivity
•Tests for Pyrogenicity
•Tests for Systemic toxicity (acute)
•Test for subacute and subchronic toxicity
• Extractable and Leachable testing

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Antibody Services
Customized Antibody Preparation and Services for Research and Drug Discovery
•Leading research antibody provider in the U.S. and China with a mature distribution and logistics network
•Custom antibody and antigen development to support both diagnostic and research applications
•Access to WuXi AppTec’s clinical trial infrastructure for companion diagnostics development
•Over 57,000 cataloged RUO Antibodies

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LTD’s Core Competitive Advantages
Transactional science, from preclinical to clinical , from laboratory to ward beds.
Platform of drug development ,clinical diagnostic and medical device testing.
Resource
•Talent Resource
•Financial Strength
•Global Footprint
Qualification
•1
st
CMC platform in China inspected by FDA
•1
st
GLP preclinical lab in China double certified
with an OECD member country with CFDA and
FDA inspections
•1
st
GLP/GCP bioanalytical lab in China to pass
FDA, OECD and CFDA inspections
Capability
•Well established base
with pharmaceutical and
biotechnology companies
•Bridging pharmaceutists,
doctors and patients

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ltd.wuxiapptec.com
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Transforming ideas into the best healthcare products through
integrated testing solutions