WuXi AppTec

WuXi AppTec Overview

Biologics Services
WuXi AppTec offers the following Biologics Services:

Development Services
• Novel Antibody Discovery Services
• Discovery Biology Services
• Antibody Target Identification and Screening
• Cell Line & Construction
• Assay Development
• Formulation Development
• Upstream (Cell Culture) Process Development
• Downstream (Purification) Process Development
• Technology Transfer

Testing Services
• Toxicology
• Biodistribution Studies
• ADME/DMPK
• Safety Pharmacology
• In-Life Efficacy Studies
• Assay Validation
• Product/Reference Standard Characterization
• Cell Line Characterization
• Lot Release Testing
• Microbial Inactivation/Clearance Validation Studies
• Viral Clearance/Inactivation Studies
• Stability Studies
• Vial & Package Integrity Testing
• Environmental Monitoring
• Microbiology Testing
• Virology Testing
• Molecular Biology Testing
• In-Life / In vivo Testing
• Cell Biology

Manufacturing Services
• cGMP Cell Banking
• cGMP Manufacture of Cellular Therapeutics
• cGMP Manufacture of Recombinant Proteins
• cGMP Manufacture of Monoclonal Antibodies
• Final Drug Product Formulation and Fill
• R&D, GLP & GMP Cell Stock Manufacturing (for cell lines used for drug screening or testing)


Pharmaceutical Services
WuXi AppTec offers the following Pharmaceutical Services:

Discovery Services
• Synthetic & Medicinal Chemistry
• Analytical Chemistry
• Discovery Biology
• Safety Pharmacology
• Drug Metabolism and Pharmacokinetics
• Bioanalytical

Development Services
• Process Research & Development
• Research & Commercial Manufacturing
• Analytical Development
• Pharmaceutical Development Services

Combination Products Services
WuXi AppTec offers the following Combination Product Services:

Combination Product Testing
• Antimicrobial Efficacy (AME)
• Microbiology for Combination Products
• Orthobiologic Services
• Package and Stability Testing for Combination Products
• Toxicology and Implant (TI)

Combination Product Manufacturing
• Aseptic processing
• Assembly and final packaging
• Method optimization
• Commercial-scale production
• Feasibility/Pilot projects

Medical Device Services
WuXi AppTec offers the following Medical Device Services:

• Proof of Concept and Process/Product Development
• Testing ServicesServices for Tissue ProductsServices for Combination Products
• Services for Tissue Products
• Services for Combination Products


Toxicology Testing Services
WuXi AppTec offers the following Toxicology Testing Services in St. Paul, and Suzhou:

• Acute Toxicity
• Repeat Exposure
• Genotoxicity (in vitro and in vivo)
• Tumorigenicity/Carcinogenicity
• Blood and Lymph Sampling
• Immunotoxicity
• Biodistribution and in vivo