Overview of WuXi AppTec Medical Device Preclincal Testing Services

1. The Leader in Combination Product Services
WUXI APPTEC

2. A Leading Pharmaceutical, Biotech and Medical Device
R&D Outsourcing Company with a Global Platform
Headquarters Shanghai, China
Laboratory services, consisting of synthetic and medicinal chemistry, DMPK/ADME, biology,
microbiology, In Vivo pharmacology, toxicology, pharmaceutical development, analytical
Service Offerings services, biopharmaceutical, in vitro and in vivo biocompatibility testing and efficacy testing
Manufacturing services, focusing on advanced intermediates, active pharmaceutical
ingredients (APIs), and biologics-based manufacturing, testing and related services
Employees 4,142 employees (3,721 in China and 421 in the US)
~ 2.0 million sq. ft. lab, animal facilities and manufacturing space
China:
► 1 million ft² total research facilities in Shanghai and Tianjin
► 291,000 ft² total cGMP(1) quality process development and manufacturing facilities in
Facilities Shanghai
► 314,000 ft² drug safety evaluation center in Suzhou
United States:
► 208,000 ft² total three state-of-the-art FDA-registered facilities in St. Paul, Philadelphia
and Atlanta
Over 800 clients worldwide including 110 for pharmaceutical services and 700 for biologics,
Customers combination product and device services
100% repeat business from top 10 customers
Note: (1) Current good manufacturing practice

3. Facilities in the U.S.
• 83,000 ft² FDA-registered facility for in vitro and in vivo biocompatibility, toxicology, contract
cGMP manufacturing and processing for tissue-based products, in St. Paul, US
• 50,000 ft² FDA-registered facility for microbiology, medical device chemistry, sterilization
validations, package testing in Atlanta, US
• 75,000 ft² FDA-registered facility for process development, cGMP manufacturing of cell banks
and cellular therapeutics, cell biology, molecular biology, virology, analytical services, viral
clearance studies in Philadelphia, US
Philadelphia Atlanta St. Paul
2

4. Facilities in China
Approximately 1,000,000 ft² R&D facility for chemistry, bio-analytical, discovery biology, DMPK and
process research in Shanghai, China
253,000 ft² R&D facility for chemistry in Tianjin, China
293,000 ft² cGMP-quality process development and manufacturing plant in Shanghai, China
22,000 ft² cGMP-quality formulation pilot plant in Shanghai, China
58,000 ft² large- and small-animal facilities currently in operation (China and US)
314,000 ft² GLP pre-clinical drug safety testing facility in Suzhou, China
Shanghai Jinshan, Shanghai
Tianjin Suzhou
GLP pre‐clinical
drug safety
testing
3

5. Pre-Clinical Testing Facilities
• 82,000 ft² FDA-registered facility for in vitro and in vivo biocompatibility, toxicology, contract
cGMP manufacturing and processing for tissue-based products, in St. Paul, US
• 314,000 ft² GLP pre-clinical drug safety testing facility in Suzhou, China
St. Paul Suzhou

6. WuXi AppTec Service Portfolio
Guidance and Services Across Therapeutic Deliveries
Medical Device
• Testing Programs
• Cell Therapy and Specialty Ortho Bio Manufacturing
Biologics
• Testing Programs
Pharmaceutical
• Laboratory Discovery Services
• Development and Manufacturing Services

7. Convergence
Combination
Products

8. Services & Guidance to Meet Regulatory Requirements

9. WX Combination Product Platforms