wuxi apptec medical device preclincal testing services
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Overview of WuXi AppTec Medical Device Preclincal Testing ServicesTRANSCRIPT
The Leader in Combination Product Services
WUXI APPTEC WUXI APPTEC
A Leading Pharmaceutical, Biotech and Medical Device R&D Outsourcing Company with a Global Platform
Note: (1) Current good manufacturing practice
Shanghai, ChinaHeadquarters
Laboratory services, consisting of synthetic and medicinal chemistry, DMPK/ADME, biology, microbiology, In Vivo pharmacology, toxicology, pharmaceutical development, analytical services, biopharmaceutical, in vitro and in vivo biocompatibility testing and efficacy testingManufacturing services, focusing on advanced intermediates, active pharmaceutical ingredients (APIs), and biologics-based manufacturing, testing and related services
Service Offerings
4,142 employees (3,721 in China and 421 in the US)Employees
~ 2.0 million sq. ft. lab, animal facilities and manufacturing spaceChina:► 1 million ft² total research facilities in Shanghai and Tianjin► 291,000 ft² total cGMP(1) quality process development and manufacturing facilities in
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
Facilities
Over 800 clients worldwide including 110 for pharmaceutical services and 700 for biologics, combination product and device services100% repeat business from top 10 customers
Customers
2
Facilities in the U.S.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
3
Approximately 1,000,000 ft² R&D facility for chemistry, bio-analytical, discovery biology, DMPK and process research in Shanghai, China253,000 ft² R&D facility for chemistry in Tianjin, China293,000 ft² cGMP-quality process development and manufacturing plant in Shanghai, China22,000 ft² cGMP-quality formulation pilot plant in Shanghai, China58,000 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
Tianjin Suzhou
Jinshan, Shanghai
GLP pre‐clinical drug safety testing
Facilities in ChinaFacilities in China
• 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
PrePre--Clinical Testing FacilitiesClinical Testing Facilities
WuXi AppTec Service PortfolioWuXi AppTec Service Portfolio
Guidance and Services Across Therapeutic DeliveriesMedical Device
• Testing Programs• Cell Therapy and Specialty Ortho Bio Manufacturing
Biologics • Testing Programs
Pharmaceutical• Laboratory Discovery Services• Development and Manufacturing Services
Convergence
Combination Products
Combination Products
Services & Guidance to Meet Regulatory RequirementsServices & Guidance to Meet Regulatory Requirements
WX Combination Product PlatformsWX Combination Product Platforms