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GMP cell banking is a crucial process within biopharmaceutical development, significantly influencing the entire CMC lifecycle. A high-quality, regulatory-compliant, and well-stored cell bank is essential for maintaining a secure and reliable supply of the producer cell line for process development activities and clinical trial, and commercial production.

At WuXi Biologics, we are committed to supporting your biopharmaceutical pipeline with comprehensive, rapid, cGMP cell banking, testing and storage services for mammalian cell lines. Our one-stop services enable a ≤ 4 months delivery timeline from seed cell receipt to full cell bank release. Our storage facilities offer reliable protection for your cell banks with global delivery capabilities.

In August 2024, our cell banking facilities were reissued an EMA GMP certificate to provide cell banking and storage services for three projects.


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Key Features

Flexible, fast and high-quality cell banking services

Global regulatory compliance

  • EMA, MHLW & NMPA certified facilities
  • Meet global regulations (EMA, Chinese pharmacopoeia, ICH)

Extensive banking experience

  • 840+ GMP cell banks created during past 8 years
  • 150+ tech transfers from clients
  • 100% success rate
  • Wide variety of cell line and cell bank types
    • Master Cell Banks (MCBs)
    • Manufacturers Working Cell Banks (WCBs)
    • End of Production Cell Banks (EOPCs)

Strong supporting team

  • Dedicated project team across global sites
  • Operators with an average industry experience of 5 years

Rapid delivery

  • 22 GMP cell banking suites providing extensive capacity and extremely flexible scheduling
  • ≤4 months for a complete cell banking timeline, including pre- and post- bank biosafety testing and QA release

Reliable storage solution with global delivery

Secure storage

  • Strict Access Control
  • Consistent online monitoring system
  • 24/7 facility monitoring
  • Precise temperature monitoring, control and alarm mechanisms
  • Dual-location backup strategy available in the USA, Germany, Ireland, or two cities within China

Reliable shipping

  • Global delivery by qualified vendors
  • Validated transportation process
  • Rich experience for exportation & importation with hands-on support by our experts

Storage stability service

  • Customized storage stability monitoring program
  • Meets global regulatory requirements

Service Highlight

Electronic system

MasterControl System for electronic batch records and e-logbooks

SAP System to manage cell bank inventory

Efficient tech-transfer

Transferred 140+ client cell lines or cell bank processes

Provide MCBs, WCBs and EOPCs for future biopharmaceutical production

Process optimization

Expertise in addressing cell growth issues like low viability, recovery rate, and vial-to-vial differences through our versatile toolboxes in culture process, and banking development.

High-density cell banking

Up to 100 x 106 cells/mL cell bank by using perfusion cell culture methods

Shorten the production seed train by five to six days

Connect with our Experts

Let’s discuss your project needs.
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