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Biomanufacture of Monoclonal Antibodies

The Biomanufacture of Monoclonal Antibodies unit of the NBC2 global biomanufacturing curriculum provides curricular material for each step of the process for a producing monoclonal antibody biotheraputics.

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

  4. ⇰   Batch Record: Anti-IL-8 mAb Production from CHO DP-12 Cells
  5. ⇰   Batch Culture of anti-IL-8 Monoclonal Antibody secreting CHO DP-12 Cells SOP
  6. ⇰   Applikon ez-Control Bioreactor Operation SOP
  7.  
  8. Upstream Quality Control
  9. ⇰   Glucose Determination Assay SOP
  10. ⇰   Lactate Determination Assay SOP
  11. ⇰   Measurement of Glucose and Lactate Concentrations using the YSI 2900 Biochemistry Analyzer SOP
  12. ⇰   Oakton PC 700 Bench Series pH/ Conductivity/°C/°F Meter SOP
  13. ⇰   Trypan Blue Cell Viability Assay SOP
  14. ⇰   Quantitation of CHO DP-12 derived Humanized Mouse anti-Human IL-8 Monoclonal Antibody by ELISA SOP
  15.  
  16. Downstream Processing
  17. Tangential Flow Filtration
  18. ⇰ End of Run anti-IL8 mAb Process: Harvest, Centrifugation, TFF Centrifugation SOP
  19. ⇰ Batch Record for Downstream Processing of Anti-IL8 mAb: TFF Operation
  20.    
  21. ÄKTA Purification System
  22. ⇰ mAb Downstream Process Flow Chart   
  23. ⇰ Downstream Process Batch Record: Isolation of Anti-IL8 mAb from CHO Cells:
  24. Chromatography Operation
  25. ⇰ Operation of ÄKTA pure Chromatography System SOP
  26. ⇰ Isolation of Anti-IL8 mAb from Conditioned Medium by Protein A
    Affinity Chromatography SOP
  27.     
  28. BioRad Biologics LP Purification System
  29. ⇰ Biologic LP Chromatography System Operation SOP
  30. ⇰ Batch Record: Downstream Process Isolation of Anti-IL8 mAb from CHO Cells: Chromatography Operation
  31. ⇰ Isolation of Anti-IL8 mAb by Protein A Affinity Chromatography SOP
  32.  
  33. Downstream Quality Control
  34. ⇰ Fisher Scientific Vertical MiniGel System SOP
  35. ⇰ SDS-PAGE SOP
  36. ⇰ Quantitation of CHO DP-12 derived Humanized Mouse anti-Human IL-8 Monoclonal Antibody by ELISA SOP
  37. ⇰ Monoclonal Antibody Aggregate Testing by HPLC Analysis SOP
  38.  
  39. Equipment Lists
  40. ⇰   Equipment & Reagent List for Upstream Processing

  41. ⇰   Equipment & Reagent List for Downstream Processing

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