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  1.  
  2. The Downstream Processing unit of the NBC2 global biomanufacturing curriculum provides an overview of the downstream purification process for a typical monoclonal antibody-based theraputic, starting with the bioreactor harves pool and finishing with pre-formulation, pure drug product.
  3.  
  4. Production Units
  5. The production units of the NBC2 global biomanufacturing curriculum discusses the most important aspects of biomanufacturing.  Under each area you will find the textbook chapter, SOPs, and related curriculum materials.
  6. 1. Upstream Processing
  7. 2. Downstream Processing
  8. 3. Process Development
  9.  
  10. TEXTBOOK CHAPTER
  11. Chapter 11: Downstream Processing
  12.  
  13. BATCH RECORDS
  14. Batch Record: tPA Production from CHO Cells Downstream Process Biologics LP System
  15. Batch Record: tPA Production from CHO Cells AKTA Pure Chromatography Operation
  16. Batch Record: HSA Production from Pichia pastoris Downstream Processing
  17.  
  18. SOPs
  19. Affinity Chromatography of HSA SOP
  20. Anion Exchange Chromatography of GFP using the AKTA Pure System SOP
  21. BioLogic LP Chromatography System Operation SOP
  22. BioLogic LP HIC Chromatography of GFP SOP
  23. Cation Exchange Chromatography of tPA using the AKTA Pure System SOP
  24. End-of-Run tPA Process: Harvest, Centrifugation, pH Adjustment SOP
  25. Ion Exchange Chromatography of tPA on the Biologics LP System SOP
  26. Isolation of mAb (anti IL-8) from Conditioned Medium by Protein A Affinity Chromatography on-         the AKTA Pure Chromatography System SOP
  27. Lysine Affinity Chromatography of tPA on the AKTA Pure System SOP
  28. Millipore Pellicon XL Tangential Flow Filter SOP
  29. Millipore Tangential Flow and Diafiltration Using Pellicon XL Device SOP
  30. Operation of AKTA Pure Chromatography System SOP
  31. Tangential Flow Filtration of HSA Process SOP

 

  1. Other Resources:
  2. VIRTUAL LABS
  3. Single Use Biomanufacturing
  4. username: Your Email Address
  5. password: qcbtc
  6. By Bruce van Dyke at Quincy College
  7.  
  8. Virtual Tour of a Biomanufacturing Facility
  9. By Amgen
  10.  
  11. Biomanufacturing e-Learning Resources
  12. By NC Bionetwork
  13.  
  14. Chromatography
  15. By NC Bionetwork
  16.  
  17. Downstream Processing Virtual Learning Module
  18. By NC Bionetwork
  19.  
  20. GFP biomanufacturing interactive video course
  21. By NC Bionetwork
  22.  
  23. Lypholization
  24. By NC Bionetwork
  25.  
  26. VIDEO
  27. Bioprocessing Part 2 - Separation and Recovery (11 mins)
  28. By NC Bionetwork
  29.  
  30. Bioprocessing Part 3- Purification (20 mins)
  31. By NC Bionetwork
  32.  
  33. SKILL STANDARDS
  34. Downstream Processing Skill Standards
  35.  
  36. Additional Resources
  37. Downstream Process Flow-Chart
  38.  
  39. AKTA pure 25 New Owner’s Introduction
  40.  
  41. NEWS
  42. Sterility Assurance in Fill/Finish Operations
  43.  
  44.  
  45. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 
  46. Introduction to Biomanufacturing Master Glossary
downstream processing,sop
Affinity Chromatography of HSA SOP

SOP from Pichia pastoris - HSA Core Production Manual  

downstream processing
AKTA Pure 25 New Owner's Introduction

An informative guide for new AKTA Pure owners, developed by Montgomery County Community College

introduction,upstream processing,downstream processing
Amgen Virtual Tour of a Biomanufacturing Facility

Take a virtual tour of Amgen's biomanufacturing facilities including their cell culture, recovery and purification, and formulation/distribution...

downstream processing
Anion Exchange Chromatography of GFP using the AKTA Pure System

SOP developed by Montgomery County Community College

downstream processing
Batch Record: tPA Production from CHO Cells AKTA Pure Chromatography Operation

Batch record for tPA downstream process developed by Montgomery County Community College   

downstream processing
Batch Record: tPA Production from CHO Cells Biologics LP System

Batch record developed by Montgomery County Community College   

Load More Resources
File
Chapter 11 of Introduction to Biomanufacturing 
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File
Production Unit Overview for chapters 10-12 of Introdution to Biomanufacturing 
View File

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