WuXi AppTec

WuXi AppTec is a global CRDMO offering integrated R&D and manufacturing services for the pharmaceutical and life sciences industries. They specialize in sterilization and microbiology testing, supporting partners in bringing breakthrough treatments to patients worldwide.

WuXi AppTec is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) dedicated to advancing healthcare innovation. With a comprehensive, end-to-end platform, they provide essential R&D and manufacturing services to pharmaceutical and life sciences partners across Asia, Europe, and North America. Specializing in areas such as sterilization and microbiology testing, WuXi AppTec collaborates with nearly 6,000 partners in over 30 countries. Their mission is to enable innovation and support the development of groundbreaking treatments, guided by the vision that every drug can be made and every disease can be treated. Their commitment to quality and collaboration is demonstrated through successful FDA inspections and recognition for ESG initiatives. WuXi AppTec is a trusted partner for companies seeking to accelerate the delivery of life-changing therapies to patients globally.

About

**Who they are**
WuXi AppTec is a global CRDMO (Contract Research, Development, and Manufacturing Organization) that provides integrated R&D and manufacturing services for the pharmaceutical and life sciences industries. They operate across Asia, Europe, and North America, supporting nearly 6,000 partners in over 30 countries.

**Expertise & scope**
* Specializes in sterilization and microbiology testing.
* Offers integrated, end-to-end services.
* Supports partners in bringing breakthrough treatments to patients.
* Focuses on advancing healthcare innovation.

**Reputation / proof points**
* Operations across Asia, Europe, and North America.
* Works with nearly 6,000 partners across 30+ countries.
* Changzhou and Taixing API Sites Successfully Pass FDA Inspections.

Additional information

WuXi AppTec's comprehensive CRDMO platform is designed to support pharmaceutical development from early-stage research through to manufacturing. Their services in sterilization and microbiology testing are crucial for ensuring the safety and efficacy of pharmaceutical products. The company emphasizes collaboration and innovation to help clients accelerate the delivery of new treatments to patients worldwide. Their global presence and experience with a large number of partners indicate a capacity to handle diverse project needs and regulatory landscapes.

Key Highlights

  • WuXi AppTec is a global CRDMO offering integrated R&D and manufacturing services. Source
    “WuXi AppTec is a global CRDMO offering integrated R&D and manufacturing services for the pharmaceutical and life sciences industries.”
  • Specializes in sterilization and microbiology testing. Source
    “They specialize in sterilization and microbiology testing, supporting partners in bringing breakthrough treatments to patients worldwide.”
  • Supports nearly 6,000 partners across 30+ countries. Source
    “We are privileged to work alongside nearly 6,000 partners across 30+ countries, supporting their efforts to bring breakthrough treatments to patients.”
  • Operations span across Asia, Europe, and North America. Source
    “With operations across Asia, Europe, and North America, we offer integrated, end-to-end services through our unique CRDMO (Contract Research, Development, and Manufacturing Organization) platform.”

Certifications & Trust Signals

  • WuXi AppTec's Changzhou and Taixing API Sites Successfully Pass FDA Inspections. Source
    “WuXi AppTec’s Changzhou and Taixing API Sites Successfully Pass FDA Inspections.”

Buyer Snapshot

Best for
  • Pharmaceutical and life sciences companies
  • Companies seeking integrated R&D and manufacturing support
  • Providers needing sterilization and microbiology testing
How engagement typically works
  • Collaborative partnerships
  • End-to-end service integration
Typical deliverables
  • Sterilization testing reports
  • Microbiology testing reports
  • Integrated R&D and manufacturing support
Good to know
  • Best when requiring specialized sterilization and microbiology expertise within a broader CRDMO framework.
HQ: Shanghai, China
Languages: English
Timezones: UTC+8
Status: listed

Services & Capabilities

Sterilization + Microbiology Validation

Countries: United States, United Kingdom, Switzerland, China, Singapore, Europe, Asia
Industries: Medical Devices
Sterilization Methods Supported: EtO (Ethylene Oxide)
Validation Types Offered: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Full validation (IQ/OQ/PQ), Revalidation
Microbiology Tests Offered: Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring
Standards Supported: ISO 11135 (EtO), ISO 11737-1 (Bioburden), ISO 11737-2 (Sterility)
GMP Compliant: Yes
Glp Compliant: Yes
Has In House Sterilization: Yes
Has In House Microbiology: Yes
Regions Served: Asia, Europe, North America

Additional sterilization_microbiology_testing Details

Sterilization Methods Supported
EtO (Ethylene Oxide), Steam (Moist Heat), Gamma Radiation, E-Beam, X-Ray, Plasma, Vaporized Hydrogen Peroxide
Validation Types Offered
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
Microbiology Tests Offered
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Sample Return Policy
Dispose
Minimum Project Size
$25-50k
Pricing Model
Custom
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