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Biomanufacture of Monoclonal Antibodies

  1. Upstream Processing
  2. ⇰  mAb Upstream Process Flow Chart

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