Fully Integrated Solutions

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1 New Jersey Nanjing Suzhou Wuhan Tianjin Shanghai 107 Morgan Lane Plainsboro NJ U.S.A. 1 Hengfei Road Economic & Technological Development Zone Nanjing China 1318 Wuzhong Avenue Wuzhong District Suzhou China 666 GaoXin Road, Wuhan East Lake Hi-tech Development Zone Hubei China 111 Huanghai Road Tianjin Economic-Technological Development Area (TEDA) Tianjin China 288 Fute Zhong Road Waigaoqiao Free Trade Zone Shanghai China Fully Integrated Solutions Contact us ltd.wuxiapptec.com China U.S. Europe Tel: +86(21) info_ltd@wuxiapptec.com Tel: +1(609) info_ltd@wuxiapptec.com Tel: info_ltd@wuxiapptec.com LTD201609B2 WuXi AppTec

2 2 3 Our Vision WuXi AppTec (LTD) "We provide a world class, fully integrated testing solution enabling scientists to transform their ideas into the best provides a comprehensive and integrated testing healthcare products, moving science from research bench to platform for drug and medical device development. hospital bed, in order to better serve our community. With operations in both China and the U.S., LTD Our drug discovery and development service and medical provides ser vices and solutions in analytical device testing experience will enable doctors to better treat chemistry, in vivo pharmacology, drug metabolism the patients and patients beneficial from precious medicare." and pharmacokinetics, bioanalysis, toxicology, medical device testing and customized antibody and reagent preparation. Jason Liu Jason Liu, PhD SVP & COO, Global Compliance 2009 Passed MPA Bioanalytical Laboratory 2010 Toxicological Animal Facility Received AAALAC Accreditation Passed FDA Toxicological Laboratory New Jersey Site Passed Received GLP Certificate FDA and EPA from CFDA 2012 Passed CFDA Toxicological Laboratory Received GLP Certificate from OECD Toxicological Laboratory Passed CFDA Passed MPA and CFDA Passed FDA and CFDA Toxicological Animal Facility Received Exemplary Commendation from AAALAC New Jersey Site Passed FDA and EPA Toxicological Laboratory Passed FDA and OECD New Jersey Site Passed FDA 2015 Passed CFDA Toxicological Animal Facility Passed AAALAC Bioanalytical Laboratory Passed CFDA and OECD 2016 Passed FDA, MPA and CFDA Toxicological Animal Facility Passed OECD Bioanalytical Laboratory Passed CFDA and OECD Central Lab Received CAP Certificate New Jersey Site Passed EPA

3 4 5 Fully Integrated Testing Platform DMPK HTS/MTS Permeability Stability in biological solutions Metabolic stability Aanalytical Services Analytical chemistry Physicochemical property measurement Hit-to-Lead Bioanalytical Services LC-MS/MS platform (CTC/DLW, ADDA, Multiplex LC, UPLC-MS/MS) Medical Device Testing Biocompatibility test Chemistry test Microbiology test Discovery Package Lead Optimization Candidate Device Package Medical Device Testing IND/NDA Package Preclinical Clinical CMC Toxicology General toxicology Genetic toxicology Safety pharmacology Reproductive toxicology Aanalytical Services Method development & validation Compound characterization & batch release Stability study Regulatory CMC Safety Bioanalytical Services Clinical chemistry Immunogenicity Small/large molecure bioanalysis Lead Optimization Toxicology Early diagnosis testing Mini Ames DMPK PK/ADME Permeability Drug-drug and transporter interactions Metabolite ID Aanalytical Services Analytical chemistry Bioanalytical Services Large molecule Small molecule Biomarker (soluble, cell, tissue, genetic) Peptide Regulatory and Technical Program Management Regulatory and Technical Program Management Initiation & Project Evaluation Custom- Built Packages Multiple Study Designs Regulatory and technical Monitoring Process and Studies, Result Discussion and Consultation Integration of Individual Study Reports, Submission Documents Preparation Advance Continuous Regulatory and technical Support for Clinical Development Regulatory Affairs Regulatory Affairs Global submission: FDA, CFDA, EMA and other regions IND/CTA ANDA Product Maintenance Submission Pharmacology Pharmacology In vivo efficay (PD) ADME DMPK Permeability Plasma protein binding RBC partitioning DDI (CYP inhibition, induction, phenotyping) Transporter profiling Metabolite ID (in vitro/in vivo) MIST studies PK/bioavailability Allometric scaling PB/PK modeling (GP + ) Radiolabeled and unlabeled ADME Tissue distribution (QWBA and QTD) Route of excretion Bioanalytical Services Biomarker analysis (soluble, cell, tissue, genetic) Small/large molecule bioanalysis (GLP-like/GLP)

4 6 7 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 Analytical Service Unit (ASU) End-to-end analytical service provider from discovery to commercialization One of the largest stability storage and testing facilities in the world The largest chiral and achiral separation facility in China FDA, CFDA & MPA-compliant Impurity Isolation and Identification Isolation and identification of impurity/degradation products Regulatory CMC For global and China submission Full CMC package by dedicated technical writing group Physicochemical Characterization & Excipient Release 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...

5 8 9 Early and Definitive In Vitro ADME Physicochemical characterization Permeability DMPK Metabolism and clearance CYP inhibition/induction/phenotyping FDA, CFDA and AAALAC inspected Plasma protein binding and RBC partitioning Global operation both in China and U.S. Transporter drug-drug interactions A comprehensive ADME and PK service provider from HTS through NDA filing Metabolite identification Integrated with Biology and MedChem for streamlined lead optimization Early and Definitive In Vivo ADME All major animals from mouse to cynomolgus monkey A variety of common & customizable surgical models In vivo 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 Radiolabeled ADME: mass balance, routes of excretion (14C and 3H) Tissue distribution:qwba (quantitative whole-body autoradiography) and QTD (quantitative tissue dissection) In Vivo Pharmacology (Rodent and NHP) Metabolic disease models (obesity, diabetes, lipid metabolism disorders) Live disease models (NAFLD/NASH, liver fibrosis) Central nervous system (CNS) disease models (Parkinson, stroke) Autoimmune disease model (rheumatoid arthritis) Other disease model (wound healing)

6 10 11 Bioanalytical Services (BAS) One of the largest bioanalytical labs in Asia, including global operation in U.S. The only bioanalytical lab in China inspected by the FDA, EMA, OECD and CFDA; US Lab FDA inspected since 2004 In-house, custom reagents for large molecule assays Ultrasensitive pg/ml LLOQs in small molecule LC-MS/MS Samples managed by Watson LIMSTM Small Molecule Bioanalysis Generic and Biosimilar Studies Assay development, validation and sample analysis using LC-MS/MS Free-to-use methods for the top biosimilars and generic drugs Large Molecule Bioanalysis Biomarker Analysis Assay development, validation and sample analysis for drug PK, ADA and Nab assays using immunochemistry techniques Assay development, validation and sample analysis for soluble, cell and tissue biomarkers (Luminex, FACS, Ventana Discovery (ELISA, MSD, Gyros) or LC-MS Ultra) Large Molecule Assay Reagent Development Central Lab Services mab and pab generation, purification, labeling and characterization Safety testing, clinical trial supplies, sample logistics and storage for clinical trials Custimized antibody for PK, ADA, host cell protein (HCP) testing

7 12 13 General Toxicology Developmental and Reproductive Genetic Toxicology Safety Pharmacology Early diagnosis testing (EDT) Toxicology Ames assay CNS (rodent and non-rodent) Chromosomal aberration assay (CHO-WBL cell and Respiration (rodent and non-rodent) Dose-ranging or MTD studies Single dose (acute toxicity) Repeat dose (subacute, subchronic and chronic) Dose-ranging study on embryo-fetus development in rats, rabbits Definitive study on embryo-fetus development in rats, rabbits with TK (Seg II) Study on fer tilit y and early development to implantation in rats (Seg I) human lymphocyte) Micronucleus assay (rat and mouse) Micronucleus assay (CHO-WBL cell) Implanted cardiovascular telemetry (dog, NHP, minipig) Non-invasive DSI JET assessments for biologics Fully validated DSI Ponemah system for data Immunotoxicology Tissue cross reactivity (human tissues) collection and analysis herg assay via manual patch clamp (Biology) Immunogenicity/ADA Toxicology (TOX) AAALAC, FDA, OECD and CFDA-inspected A premier toxicology service provider in China The 1st CRO in China with a on-staff ACLAM-certified veterinarian Comprehensive toxicology packages supporting China and global IND/NDA filings Immunophenotyping Anatomic and Clinical Pathology T-cell-dependent antibody responses (TDAR) Toxicological or immunopathology

8 14 15 Antibody Services Leading research antibody provider in the U.S. and China Custom antibody and antigen development to support both diagnostic and research applications Medical Device (MD) Access to WuXi AppTec s clinical trial infrastructure for companion diagnostics development End-to-end testing services including material screening, product design and regulatory testing Biocompatibility Test Cytotoxicity test Irritation Sensitization Hemocompatibility General toxicity test Pyrogenicity Genetic toxicology Implantation Chemistry Test Analytical chemistry test Ethylene oxide test Extractable/Leachable programs Physical properties testing Wet chemistry Support for Chinese and international clients to register their product with the China Food and Drug Administration (CFDA) and for Chinese clients to register their products outside of China Fully compliant with FDA, OECD and CFDA GLP requirements AAALAC-inspected animal facilities ISO/IEC 17025(under evaluation) Microbiology Test Controlled environment test Growth promotion test BI enumeration BI sterility test ELITE Custom Services ELITE Polyclonal Antibody Services ELITE Monoclonal Antibody Services Anti-Host Cell Protein (Anti-HCP) Antibodies Integrated Service Anti-Drug Antibody (ADA) Integrated Service Platform Antibody Validation Services ELITE Peptide Synthesis ELITE Protein Expression ELITE Services for Drug Discovery ELITE Modification-state-specific Antibody services ELITE Custom Flow Cytometry Services ELITE Custom Phage Display Antibody Services