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Biomanufacture of Monoclonal Antibodies

  1. Upstream Processing
  2. ⇰   Batch Record: Anti-IL-8 mAb Production from CHO DP-12 Cells
  3. ⇰   Batch Culture of anti-IL-8 Monoclonal Antibody secreting CHO DP-12 Cells SOP
  4. ⇰   Applikon ez-Control Bioreactor Operation SOP
  5.  
  6. Upstream Quality Control
  7. ⇰   Glucose Determination Assay SOP
  8. ⇰   Lactate Determination Assay SOP
  9. ⇰   Measurement of Glucose and Lactate Concentrations using the YSI 2900 Biochemistry Analyzer SOP
  10. ⇰   Oakton PC 700 Bench Series pH/ Conductivity/°C/°F Meter SOP
  11. ⇰   Trypan Blue Cell Viability Assay SOP
  12. ⇰   Quantitation of CHO DP-12 derived Humanized Mouse anti-Human IL-8 Monoclonal Antibody by ELISA SOP
  13.  
  14. Downstream Processing
  15.    Tangential Flow Filtration
  16.    ⇰ Batch Record for Downstream Processing of Anti-IL8 mAb: TFF Operation
  17.    ⇰ End of Run anti-IL8 mAb Process: Harvest, Centrifugation, TFF Centrifugation SOP
  18.  
  19.    ÄKTA Purification System
  20.    ⇰ mAb Downstream Process Flow Chart   
  21.    ⇰ Downstream Process Batch Record: Isolation of Anti-IL8 mAb from CHO Cells:
  22. Chromatography Operation
  23.    ⇰ Operation of ÄKTA pure Chromatography System SOP
  24.    ⇰ Isolation of mAb (anti IL-8) from Conditioned Medium by Protein A
    Affinity Chromatography on the ÄKTA pure Chromatography System SOP
  25.     
  26.    BioRad Biologics LP Purification System
  27.    ⇰ Biologic LP Chromatography System Operation SOP
  28.    ⇰ Batch Record: Downstream Process Isolation of Anti-IL8 mAb from CHO Cells: Chromatography Operation
  29.    ⇰ Isolation of anti-IL8 mAb by Protein A Affinity Chromatography on the Biologic LP Chromatography System SOP
  30.  
  31. Downstream Quality Control
  32.    ⇰ Fisher Scientific Vertical MiniGel System SOP
  33.    ⇰ SDS-PAGE SOP
  34.    Quantitation of CHO DP=12 derived Humanized Mouse anti-Human IL-8 Monoclonal Antibody by ELISA SOP
  35.  

  36. Equipment Lists
  37.    ⇰   Equipment & Reagent List for Upstream Processing
  38.    ⇰   Equipment & Reagent List for Downstream Processing
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