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Biomanufacture of Monoclonal Antibodies

This unit of the NBC2 global biomanufacturing curriculum provides curricular material for each step of the process for 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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