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 CHO DP12 Cells for production of anti-IL-8 Monoclonal Antibody SOP
6. ⇰   Bellco Spinner Flask (100mL) Cleaning and Autoclaving SOP
7. ⇰   Applikon ez-Control Bioreactor Controller 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. ⇰ Isolation of mAb (anti-IL8)  from Conditioned Medium by Protein A
    Affinity Chromatography on the AKTA pure Chromatography System 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

44.                 
45.  
46.