Literature (PDFs by Category)
WuXi AppTec Services Overview (1735 KB)
Small Molecules
Discovery Services
- Synthetic Chemistry Services (782 KB)
- Integrated Analytical and Purification Services (782 KB)
- CSU Overview (601 KB)
- Compound Management Service (703 KB)
- Chemical Reagent Service (551 KB)
- Peptide Synthesis Services (1067 KB)
- Chiral Separation Services (605 KB)
- Natural Product Center (1,020 KB)
- Nucleoside Chemistry Services (530 KB)
- Discovery Analytical Services (844 KB)
- Medicinal Chemistry Services (216KB)
- Discovery Biology Services (159 KB)
- DMPK and ADMET Services (183 KB)
- hERG Profile on QPatch (218 KB)
- Pharmacology (821KB)
- Oncology Flyer (229 KB)
- Safety Pharmacology Services (211 KB)
- Bioanalytical Services (177 KB)
- Genome Center NGS to Bioinformatics (1 MB)
Development Services
- Analytical Research and Development (147 KB)
- DNA and Gene Synthesis (271 KB)
- Pre-Formulation/Formulation Development Services (245 KB)
- GMP Separation Services (332 KB)
- Process Research and Development Services (840 KB)
- API Manufacturing (967 KB)
Toxicology
- WuXi AppTec’s Toxicology Services in Suzhou (479 KB)
- Preclinical Development of Biologics (2285 KB)
- Pre-Clinical Genetic Toxicology Services (264 KB)
- Pre-Clinical Early Diagnosis (230 KB)
- Pre-Clinical Safety Pharmacology (224 KB)
- Pre-Clinical Immunology Services (1394 KB)
- Pre-Clinical General Toxicology (225 KB)
- Pre-Clinical Toxicology (211 KB)
- Non-clinical Vaccine Development (1454 KB)
Biologics
- WuXi AppTec Services Overview (1,471 KB)
- Operational Excellence - U.S. Facilities (1,266 KB)
Services by Product Type
- Cellular Therapeutics Services (470 KB)
- Gene Therapy Services (379 KB)
- Mammalian-Derived Protein Therapeutics Services (370 KB)
- Microbial-Derived Protein Therapeutics Services (478 KB)
- Vaccine Services (510 KB)
Services by Program Type
Discovery & Development
- Cell Line Development (448 KB)
- Discovery Biology Services (159 KB)
- DMPK and ADMET Services (183 KB)
- Monoclonal Antibody (MAb) Discovery (532 KB)
- Protein Therapeutics Process Development (1,100 KB)
Manufacturing
- Cell Banking (2,165 KB)
- Cell Stock Manufacture (1,108 KB)
- Cellular Therapeutics Manufacturing (470 KB)
- Protein Therapeutics Manufacturing (337 KB)
Testing
- Bioanalytical Services(525 KB)
- Biodistribution and Expression Analysis
(Technical Sheet)(336 KB)
- Cleaning Validations (229 KB)
- DNA Sequencing Services (317 KB)
- Gene Therapy Preclinical Services (444 KB)
- Lot Release Programs (877 KB)
- Mammalian Cell Line Characterization (467 KB)
- Microbial Cell Bank Characterization (200 KB)
- Microbial Identifications (628 KB)
- Preclinical Development of Biologics (639 KB)
- Product Characterization (737 KB)
- Stability Studies(722 KB)
- Supply Chain Assessments (210 KB)
- Viral Bank Characterization (460 KB)
- Viral Clearance Data Mining Services (984 KB)
- Viral Clearance Studies (896 KB)
Additional Testing Guidelines:
Devices / Combination Products
- Services for Medical Devices – Overview (2,570 KB)
- Operational Excellence – U.S. Facilities (1,570 KB)
Biocompatibility Testing
- Biocompatibility Testing - Overview (1,760 KB)
- Biocompatibility Testing
(Technical Sheet) (447 KB)
- Interpretive Summary Reports (Biocompatibility) (334 KB)
- Japanese-Compliant Testing (137 KB)
- JMHLW to ISO Testing Comparison Biocompatibility Testing (123 KB)
- Toxicology Implant Studies (291 KB)
- White Paper: Biocompatibility Testing for Combo Products (134 KB)
- Materials Characterization - Overview (1,060 KB)
- Chemical Testing Services for Medical Devices (382 KB)
Microbiology, Process Control & Package Testing
- Microbiology & Package Testing - Overview (799 KB)
- Antimicrobial Testing Services for Industrial Products (296 KB)
- Bioburden Testing (906 KB)
- Controlled Environments Testing (302 KB)
- Custom Microbial Studies (267 KB)
- Microbial Identifications (628 KB)
- Method References for Microbiology, Chemistry & Package Testing (580 KB)
- Package System Services for Medical Devices (576 KB)
- Reusable Medical Devices [Reprocessing Validation] (663 KB)
- Sterilization Validation Programs (306 KB)
- White Paper: Laying the Foundation for a Sound Package Testing Program (264 KB)
- White Paper: Reprocessing Reusable Medical Devices – FAQs (1,030 KB)
Preclinical Studies
- Preclinical Services - Overview (1,420 KB)
(including antimicrobial efficacy, orthobiologic and wound healing studies) - Antimicrobial Efficacy: Validated In Vivo Model for Device Implants (609 KB)
- Antimicrobial In Vitro Testing for Medical Devices (912 KB)
- Biofilm Quantification (662 KB)
- White Paper: Microbial Biofilms (1,010 KB)
Catalog: Catalog of Services for Devices and Combination Products
