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WuXia™ Cell Line Development

Proven, High-Yielding Cell Line Development Platform Accepted By Regulatory Agencies Worldwide

 

WuXi Biologics offers an extensive list of CMC  (Chemistry, Manufacturing and Control) services that can be integrated and often conducted in parallel with our WuXiaTM cell line development  services – all using the same cell line platform. 


Our team of experts use sequence analysis and Artificial Intelligence (AI)-assisted codon optimization to design out undesirable product quality attributes. In addition, Next Generation Sequencing (NGS)-guided clone screening is available.

 

Sequence Analysis

 


Developability studies are availalbe to determine if the product fits to upstream and downstream processes while also obtaining product and formulation stability data. These studies are ideal if evaluating multiple product variants to choose the eventual lead molecule.


Ten EMA-certified cGMP cell bank suites are available to produce approximately 160 Master Cell Banks (MCB) and Working Cell Banks (WCB) per year.  Comprehensive in-house cell line characterization 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 development to release of GMP manufactured cell banks.


Integrated with the cell line development program we have established one of the world’s largest and most experienced process development teams to develop, optimize and validate upstream and downstream processes for eventual large-scale GMP manufacture using the same cell line platform used during all CLD activities.


WuXi Biologics’ molecular biology, cell biology and  analytical laboratories work together to provide protein expression, product quality and stability assessments for research cell banks (RCB). 


Comprehensive and wide-ranging analytical methods are available to assess the product during developability studies and cell line development. Examples include:

 

  • Purity
  • Aggregates
  • Identity
  • Titer
  • Glycan Profile
  • Binding or Potency Assay
  • Charge Variance
  • Sequence Variance
  • Post-Translational Modifications 

One-stop Cell Bank Creation

 

WuXi Biologics provides comprehensive one-stop cell banking and testing service compliant with global regulatory agencies. GMP cell bank facilities features include:

  • Suites dedicated for mammalian cell lines in suspension
  • Only Animal component-free raw materials are utilized.
  • Single direction personnel flow
  • Dedicated material flow.
  • No deviations have occurred in the GMP facilities due to environmental monitoring issues in the last 450+ days. 
  • Two storage locations in Shanghai BEFORE cell bank release. GMP storage in Shanghai and Wuxi site AFTER cell bank release .

Capacity
  • 10 GMP cell banking suites
  • 160/year GMP cell banks 
  • Automated vial filling available
Quality
  • EMAcertified
  • 100+ GMP audits passed
  • 10+ quality risk assessments cover all critical areas
  • 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

  • 5-8 years cell banking experience
  • 300+ GMP cell banks created
  • 100+  cell banks generated at WuXi Biologics used for global IND submissionss


WuXi Biologics’ Suzhou biosafety testing lab is the largest 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

EU GMP Certificate for WuXi Biologics (Shanghai)