Virology Expertise

WuXi AppTec offers the highest level of critical regulatory and technical expertise for the testing of monoclonal antibodies, recombinant proteins, cell and tissue-based therapeutics, vaccines, gene therapy products, and biologic-sourced raw materials.

Utilizing a wide variety of in vitro, in vivo, molecular and analytical methodologies, we provide a full menu of services that includes assessment of cell/viral banks and production lots for adventitious viral contaminants, and development and validation of potency/identity assays for viral vaccines and gene therapy therapeutics. WuXi AppTec is also a recognized world leader in viral clearance/inactivation validation studies.

Click on the links below to learn more about WuXi AppTec’s expertise and experience in these critical areas:


Cell and Viral Bank Characterization
Comprehensive testing programs for regulatory acceptance worldwide

Lot Release Programs
Speeding product release with rapid, reliable safety testing
 

Viral Clearance Studies
Expertise that can make the critical difference

Cleaning Validations
Preventing and responding to adventitious agent contamination
 

Gene Therapy Testing Services
Utilizing over 20 years of experience to guide you safely into clinical trials

Supply Chain Assessments
Preventing and detecting contaminants in raw materials and other components
 

Vaccine Testing Services
Expertise, experience and regulatory knowledge – regardless the type of vaccine

Key Technical Staff
The knowledgeable WuXi AppTec personnel who will help ensure a successful testing program for your biopharmaceutical