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Quality Control Shanghai (Clinical Stage)

WuXi Biologics’ Quality Control Department at the Shanghai site (QC-SH) originated from Analytical Sciences (AS) Shanghai. It transitioned to an independent Quality Control Department Shanghai (QC-SH) in December 2017 and supports WuXi Biologics MFG3 manufacturing. Coordinated with AS, MFG3 and Quality Assurance (QA), we provide quality control services for the full process of drug production.

 

QC-SH focuses on supporting BioDev projects in the clinical phase. We have six functional parts including Physicochemistry, Biochemistry, Bioassay, Raw Material, Microbiology and Environmental Monitoring and Lab Laboratory Operation. We offer services for clients including Method Lifecycle Management (MLCM), raw material spec and release testing, in-process control, DS/DP release testing and stability study, as well as environmental monitoring.

 

We have state-of-the-art instruments, electronic systems and systemic method lifecycle management. As of August 2020, we have supported over 60 projects, 100 lots production and over 1,000 method qualifications in total. Moreover, we completed audits by 48 global clients including Qualified Persons (QPs) audits and European Medicines Agency (EMA) inspection on Electron Microscopy (EM) labs.


Quality Control Shanghai (Clinical Stage)_Production


Pre-Production Readiness

QC-SH supports the pre-production preparation, ensuring the cell bank, raw material, analytical methods and device facility environment are qualified and can meet the quality standards. 

Our dedicated team supports over 35 projects annually to set up the cell bank specification, coordinate the test and release of over 70 cell banks.

 

Our Raw Materials (RM) team supports over 2,000 lots annually to complete specification setting, testing and release. 

 

Our Environment and Utility Monitoring (EM) performs routine environmental monitoring MFG3 for DS production and CB area for cell banking, completing over 140,000 samples annually.

 

Coordinated with Analytical Sciences (AS), we support 35-plus projects and have accomplished over 550 method qualification/transfers annually. We also keep tracking performance for the method lifecycle management.

 

Production Monitoring

QC-SH supports the in-process testing and monitoring to ensure the process is completed smoothly.  


Our Environment and Utility Monitoring (EM) team completes over 5,500 samples from process gas and water system annually.

 

Our testing team works 7 days a week, 24 hours a day to ensure real-time monitoring of the manufacturing progress, completing over 2,600 in-process testing annually.

 

Meanwhile, the environment monitoring is always ongoing.

 

gaswater

 


Post-Production Management

QC-SH provide post-production management for reference standard (RS) generation, DS/DP release and stability study.

We offer reference standard (RS) lifecycle management, including RS generation, aliquot, qualification, annual requalification, inventory and quality tracking. 

 

We have a comprehensive testing panel for lot release and support over 120 lot releases annually. 

 

We provide a protocol-driven stability program, including an importing stability program, pulling schedule management, sample and testing tracking. Over 1,100 stability points are completed by QC-SH annually.

 

As of August 2020, we have completed over 50 audits for 48 global clients including Qualified Persons (QPs) audits and European Medicines Agency (EMA) inspection on Electron Microscopy (EM) labs.

 

  • Appearance, Visible particles, Color, Clarity, Density Refraction
  • Bacterial Endotoxin, Subvisible Particles


  • ID: Peptide Mapping, Isoelectric Point 
  • Purity: SEC-HPLC, Charge Variant
  • Assay: Titer, Sialic Acid, N-Glycan Profile, Polysorbate 20/80


  • Identification, Spectral Analysis
  • TOC, Impurity Analysis


  • Residual Protein A, Residual HCP, Residual DNA
  • Enzyme-Linked Immunosorbent Assay (ELISA) Antigen Binding Assays
  • Fluorescence Resonance Energy Transfer (FRET) Assays


  • Sterility Tst
  • Bioburden Test
  • Bacterial Endotoxin Test