North American Suppliers Directory Index

WuXi AppTec

2540 Executive Dr.
St. Paul, MN 55120
Tel: 651/675-2000
Fax: 651/675-2005

Web: http://www.wuxiapptec.com
E-mail: info@wuxiapptec.com

WuXi AppTec is a leading global medical device, biotechnology and pharmaceutical outsourcing company with operations in China and the U.S. WuXi AppTec's three U.S.-based facilities – in St. Paul, Atlanta, and Philadelphia – are all FDA-registered. Additional qualifications include ISO certification, AAALAC accreditation, FDA registration for HCT/Ps, and AATB accreditation.

As the global leader in Combination Product Services (CPS), WuXi AppTec offers specialized programs for all types of combination products – providing manufacturers with the services they require to support efficacy claims.

Our recognized leadership in this area is built on a unique alignment of expertise, strong technical staff, and long history of testing and manufacturing services for devices, tissue products, biologics, and pharmaceuticals.

WuXi AppTec's key technical staff is exceptionally strong in areas critical to combination products – including virology, biology and biomedical engineering expertise.

Product Experience
WuXi AppTec’s many years of experience include providing comprehensive services in these selected product areas:
Implants
Stents
Orthopedics
Wound sponges
Catheters/leads
Uterine devices
Suture material
Vaccines
Gene therapy products
Humans cells
Cellular products
Monoclonals
Therapeutics
Natural products
Analgesics
Anti-infectives
Anti-inflammatories
Chemicals

Combination Product Testing
The testing services provided by WuXi AppTec specifically to support combination product efficacy claims are robust and proven successful. Clients know they can count on our exceptional capabilities and our unique expertise for comprehensive testing programs that are custom designed to meet their particular needs for each test article.

Understanding that communication between regulatory agencies, manufacturer and testing lab is critical to ensure success in combination product development, WuXi AppTec becomes part of your design team, working closely with you to help bring your product from research to proof-of- concept to regulatory submission to commercial launch.

Testing Programs
WuXi AppTec offers a comprehensive testing menu for combination products — including these highly specialized programs:

• Antimicrobial Efficacy (AME) Studies
• Toxicology + Implant (TI) Studies

Additional testing services include:

• Biocompatibility / Safety Studies
• Antimicrobial In-Vitro Testing
• Stability Storage & Analytic Testing
• Sterilization Validation Studies
• Lot Release & Raw Materials Testing
• Packaging Integrity Studies
• Pathologic Tissue Analysis

Combination Product Manufacturing
For combination products that require aseptic processing, WuXi AppTec has a long track record of providing these specialized manufacturing services. In addition to the advantages offered by WuXi AppTec's flexible facilities, knowledgeable staff and years of experience in product development, our clients have found that partnering with us allows them to consolidate their manufacturing and testing needs, which shortens timelines, reduces total cost of development and manufacturing, and improves the quality of their overall process.

Categories this company is listed under in the North American Suppliers Directory:

• Environmental-Control Products and Services: Testing/Certification/Training services (64 companies)
• R&D, Design, and Business Services: Consulting/Training services (395 companies)
• R&D, Design, and Business Services: Laboratory research (145 companies)
• R&D, Design, and Business Services: Manufacturing capabilities (375 companies)
• R&D, Design, and Business Services: Process validation/QC (234 companies)
• R&D, Design, and Business Services: Product R&D (613 companies)
• Testing Equipment and Services: Services: Components/Materials testing and analysis (257 companies)
• Testing Equipment and Services: Services: Laboratory testing (toxicology, etc.) (143 companies)
• Testing Equipment and Services: Services: Microbiology/Chemical testing and analysis (134 companies)
• Testing Equipment and Services: Services: Other testing services (365 companies)
• Testing Equipment and Services: Services: Product safety/Performance testing (262 companies)