Cell Banking

One-stop Cell Bank Creation, GMP Manufacture and Characterization

WuXi Biologics provides comprehensive one-stop EMA, PMDA and NMPA certified cell banking and cell line characterization services. Twenty-two cGMP cell bank suites are available, providing the capacity to produce over 440 Master Cell Banks (MCB), Working Cell Banks (WCB) and End of Production Cell (EOPC) banks annually. Comprehensive in-house cell line development and cell line characterization and biosafety testing services, performed per global regulatory guidelines (e.g., ICH, U.S. FDA, EMA and NMPA), are also available to provide streamlined, efficient, one-stop service from cell line engineering to release of GMP manufactured cell banks.

Our GMP cell bank facilities features include:

Suites dedicated for mammalian cell lines in suspension
Animal component-free raw materials
Single direction personnel flow
Dedicated material flow
Zero deviations in the GMP facilities due to environmental monitoring issues in the last 1,600+ days.
Two storage locations BEFORE cell bank release. GMP storage available in two separate cities AFTER cell bank release.

Capacity	22 GMP cell banking suites 440+ GMP cell banks annually Automated vial filling available
Quality	EMA, PMDA and NMPA certified suites available 270+ client GMP audits passed 10+ quality risk assessments covering all critical areas Multiple global regulatory agency certifications of the biosafety labs Media fill personnel qualification
Storage	On-line Liquid Nitrogen (LN₂) tank alarm system 7/24 personnel oversight and observation Dual storage location SAP cell bank management system Customized storage stability studies available
Experience	7+ years cell banking experience 790+ GMP cell banks created 100+ cell banks generated at WuXi Biologics used for global IND submissions

EMA Cell Bank Facility Certification
Cell Line Characterization and Biosafety Testing

EU GMP Certificate for WuXi Biologics (Shanghai)

WuXi Biologics’ Suzhou biosafety testing lab is the leading biosafety lab in the Asia Pacific (APAC) region. We provide comprehensive, validated methods that meet global regulatory guidelines (e.g, USP/EP/JP/ChP and ICH, U.S. FDA, EMA and NMPA). Services include:

Cell line characterization (PCB/MCB/WCB/EOPC )
Mycoplasma, general virus and adventitious virus assays for various biologics, and cell and gene therapies.
Viral clearance validation studies for IND and BLA.
Clinical and commercial Unprocessed Bulk (UPB) lot release services.

More information about Suzhou Biosafety Testing Click here.