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Global Quality Control (QC) Assay List

Our Quality Control (QC) labs support all WuXi Biologics clinical and commercial product GMP manufacturing sites throughout the world and work closely with Analytical Development teams to provide our customers with the highest quality testing services.  The following list of commonly conducted assays and the types of available instrumentation, although not all-inclusive, provide a snapshot on the scope and breadth of methods frequently used for lot release or stability testing of biologics and vaccines at WuXi Biologics.  If you do not see a method or instrument on this list or to inquire on our experience with a specific method / assay either in our assay development labs or QC, please contract us directly.

 

Assay Platform Example Assays Equipment / Instrument
Cell Based
  Potency MD/M5e; PE/Envision; MSD/S600; Beckma/Vicell; Labconco/A2; Thermo/ 3111
  Mycoplasma UV Nano 5; PCR Instrument
UPLC
  UP-SEC

Agilent/1290
Waters/H-Class
  Peptide Mapping

Agilent/1290
Waters/H-Class

  N-glycans

Agilent/1290
Waters/H-Class

HPLC
  SEC Agilent/1260, 1290
Waters/E2695, Arc Bio
Thermo/Ultimate 3000
Shimatzu/LC-20AR
  CEX Agilent/1260, 1290
Waters/E2695, Arc Bio
Thermo/Ultimate 3000
Shimatzu/LC-20AR
  Titer by ProA Agilent/1260, 1290
Waters/E2695, Arc Bio
Thermo/Ultimate 3000
Shimatzu/LC-20AR
  HIC Agilent/1260, 1290
Waters/E2695, Arc Bio
Thermo/Ultimate 3000
Shimatzu/LC-20AR
  PS-20/80 or other surfactant Agilent/1260, 1290
Waters/E2695, Arc Bio
Thermo/Ultimate 3000
Shimatzu/LC-20AR
  Histidine or other amino acids Agilent/1260, 1290
Waters/E2695, Arc Bio
Thermo/Ultimate 3000
Shimatzu/LC-20AR
Capillary Electrophoresis
  SDS Reduced PA800 Plus
  SDS non-reduced PA800 Plus
  iCIEF ProteinSimple/iCE3
ProteinSimple/Maurice C
Container Closure Integrity Testing (CCIT)
   Vacuum Decay PTI455
Compendial / Identity
  pH All instruments compliant to EP, USP, ChP
  Appearance All instruments compliant to EP, USP, ChP
  Endotoxin All instruments compliant to EP, USP, ChP
  Clarity All instruments compliant to EP, USP, ChP
  Degree of Opalesence All instruments compliant to EP, USP, ChP
  Color All instruments compliant to EP, USP, ChP
  Insoluble Particulate Matter All instruments compliant to EP, USP, ChP
  Recoverable/Extractable Volume All instruments compliant to EP, USP, ChP
  Filled Volume All instruments compliant to EP, USP, ChP
  Sterility 4-gloves Isoflex
  Bioburden Milliflex plus pump
BioPhysical / Spectroscopy
  Particulate Matter All instruments compliant to EP, USP, ChP
  Osmolality All instruments compliant to EP, USP, ChP
  UV280 Agilent/Cary100; C Technologies/SoloVPE
Surface Plasmon Resonance
  Antigen Binding Affinity Biacore T200; 8K
  FcRn Binding Affinity Biacore T200; 8K
ELISA
  Host Cell Protein Hamilton/Microlab Star; Biotek/ELX50; Biotek/405LS; MD/M5e; Bio-Rad/Chemidoc MP
  Residual Protein A Hamilton/Microlab Star; Biotek/ELX50; Biotek/405LS; MD/M5e; Bio-Rad/Chemidoc MP
  Potency MD/M5e; PE/Envision; Biotek/ELX405VRS
BioChemistry
  Residual DNA by qPCR Applied Biosystem 7500 & Q7
  Western Blot Invitrogen/PowerEase 500 Power Supply EI 8700; Bio-Rad/PowerPac Basic
  Karl Fisher Moisture Analysis Mettler Toledo/C30S

 


Global QC maintains multiple in-house testing Centers of Excellence including physicochemistry, biochemistry, biosafety, bioassay, microbiology, and molecular biology labs. Utilizing state-of-the-art instruments, that benchmark industry standards our QC teams provide the expertise and capacity to support our client’s manufacturing programs and to perform stand-alone testing services for a wide array of biologics and vaccines. We work, as needed, alongside our large, highly trained and experienced analytical development teams to develop customized lot release and stability testing programs designed to meet regulatory guidelines and GMP regulations.