WuXi AppTec’s corporate commitment to quality is reflected in the quality programs and systems at its U.S. sites located in Saint Paul, Minnesota; Atlanta, Georgia; and Philadelphia, Pennsylvania.
For the convenience of our clients, we are also pleased to make available the following PDFs of accreditation/registration certificates for viewing or downloading.
[Contract Manufacturing] American Association of Tissue Banks (AATB) Accreditation
[Contract Manufacturing] BSI Certificate of Registration: Quality Management System – ISO 13485:2016
[Contract Manufacturing] State of Maryland Tissue Bank Permit
[Contract Manufacturing] State of New York Provisional License for Tissue Banks
[Contract Manufacturing] State of Florida Tissue Bank Certificate
[Biocompatibility] A2LA ISO/IEC 17025:2017 Accreditation
[Chemistry] A2LA ISO/IEC 17025:2017 Accreditation
[Biocompatibility] EMA Certificate of GMP Compliance
[Biocompatibility/Contract Manufacturing] Food and Drug Administration (FDA) Drug Establishments Registration
Go to the FDA’s website on Drug Establishments Current Registration Site (access data) and in the Firm Name search field, enter Wuxi AppTec. Refer to the FDA Identifier 3002199759
[Chemistry] Food and Drug Administration (FDA) Drug Establishments Registration
Go to the FDA’s website on
Drug Establishments Current Registration Site (access data) and in the Firm Name search field, enter Wuxi AppTec. Refer to the FDA Identifier 3011125228
[Biocompatibility] Therapeutic Good Administration (TGA) of Australia GMP Certification
American Association for Laboratory Accreditation: Certificate of Accreditation – ISO/LEC 17025:2017
Food and Drug Administration (FDA) Establishment Registration and Listing for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/PS)
International Safe Transit Association (ISTA) Certificate of Membership as Certified Testing Laboratory
EMA Certificate of GMP Compliance
Food and Drug Administration (FDA) Establishment Registration and Listing for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/PS)
WuXi Advanced Therapies | CTDMO Cell and Gene Therapies
We’re the chemistry gold standard with the only program committed to doing complete characterization the first time and every time. We meet biocompatibility systemic risk and chemical characterization endpoints at a level that is markedly higher than our closest competitor.
We share our knowledge with the FDA on how to approach Biological Evaluations based on International Standards because we serve on standards committees and track regulatory inquiries and trends. It’s what gives us the inside track to be proactive partners that anticipate change.
From development through commercialization, we’re your full-service partner and strategic consultant. We’re a true extension of your team.
