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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. ⇰   Bellco Spinner Flask (100mL) Cleaning and Autoclaving SOP
  7. ⇰   Applikon ez-Control Bioreactor Operation SOP
  8.  
  9. Upstream Quality Control
  10. ⇰   Glucose Determination Assay Using Spectrophotometry SOP
  11. ⇰   Lactate Determination Assay Using Spectrophotometry SOP
  12. ⇰   Glucose and Lactate Concentration Determination using the YSI 2900 Biochemistry Analyzer SOP
  13. ⇰   Oakton PC 700 Bench Series pH/ Conductivity/°C/°F Meter SOP
  14. ⇰   Operation of Life Technologies Countess II Cell Counter SOP
  15. ⇰   Trypan Blue Assay for Cell Viability Determination SOP
  16. ⇰   Quantitation of CHO DP-12 Derived Anti IL-8 Monoclonal Antibody by ELISA SOP
  17.  
  18. Downstream Processing
  19. ⇰ FLOW CHART: mAb Downstream Process
  20.  
  21. Tangential Flow Filtration

  22. ⇰ End of Run anti-IL8 mAb Process: Harvest, Centrifugation, TFF Concentration SOP
  23. ⇰ BATCH RECORD: Downstream Processing of Anti-IL8 mAb
  24.    
  25. ÄKTA Purification System
  26. USER GUIDE: AKTA Pure 25 User Introduction
  27. ⇰ Operation of ÄKTA pure Chromatography System SOP
  28. ⇰ Purifiation of Anti-IL8 mAb from Conditioned Medium by Protein A
    Affinity Chromatography SOP
  29.     
  30. BioRad Biologics LP Purification System
  31. ⇰ Biologic LP Chromatography System Operation SOP
  32. ⇰ BATCH RECORD: Downstream Process Isolation of Anti-IL8 mAb from CHO Cells: Chromatography Operation
  33. ⇰ Isolation of Anti-IL8 mAb by Protein A Affinity Chromatography SOP
  34.  
  35. Downstream Quality Control
  36. ⇰ Fisher Scientific Vertical MiniGel System SOP
  37. ⇰ SDS-PAGE SOP
  38. ⇰ Quantitation of CHO DP-12 Derived Anti IL-8 Monoclonal Antibody by ELISA SOP
  39. ⇰ Monoclonal Antibody Aggregate Testing by HPLC SEC Analysis SOP
  40.  
  41. Equipment Lists
  42. ⇰   Equipment & Reagent List for Upstream Processing

  43. ⇰   Equipment & Reagent List for Downstream Processing

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