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  1. The Downstream Processing unit of the NBC2 global biomanufacturing curriculum provides an overview of the downstream purification process for a biotheraputic, starting with the bioreactor harvest pool and finishing with pre-formulation drug substance.
  2.  
  3. TEXTBOOK CHAPTER
  4. Chapter 11: Downstream Processing

  5. Production Unit Overview
  6.  
  7. VIRTUAL LEARNING MODULE-DOWNSTREAM PROCESSING
  8. mAb Downstream Processing

  9.  
  10. BATCH RECORDS
  11. Batch Record: tPA Production from CHO Cells Downstream Process Biologics LP System

  12. Batch Record: tPA Production from CHO Cells AKTA Pure Chromatography Operation
  13. Batch Record: HSA Production from Pichia pastoris Downstream Processing
  14.  
  15. SOPS
  16. Tissue Plasminogen Activator tPA purification:
  17. AKTA pure 25 New Owner’s Introduction
  18. Operation of AKTA Pure Chromatography System SOP
  19. Downstream Process Flow-Chart for tPA
  20. Cation Exchange Chromatography of tPA using the AKTA Pure System SOP
  21. Lysine Affinity Chromatography of tPA on the AKTA Pure System SOP
  22. Ion Exchange Chromatography of tPA on the Biologics LP System SOP
  23.  
  24. ​​Other purifications:
  25. Isolation of mAb (anti IL-8) from Conditioned Medium by Protein A Affinity Chromatography on-         the AKTA Pure Chromatography System SOP 
  26. (continue to mAb production curriculum page for further information on mAb processing)
  27. Anion Exchange Chromatography of GFP using the AKTA Pure System SOP
  28. BioLogic LP Chromatography System Operation SOP
  29. BioLogic LP HIC Chromatography of GFP SOP
  30. Affinity Chromatography of HSA SOP
  31.  
  32. UF/DF:
  33. End-of-Run tPA Process: Harvest, Centrifugation, pH Adjustment SOP
  34. Millipore Pellicon XL Tangential Flow Filter SOP
  35. Millipore Tangential Flow and Diafiltration Using Pellicon XL Device SOP
  36. Tangential Flow Filtration of HSA Process SOP
  37.  
  38. SKILL STANDARDS
  39. Downstream Processing Skill Standards

  40.  
  41. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 
  42. Introduction to Biomanufacturing Master Glossary

 

  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. Chromatography
  13. GFP biomanufacturing interactive video course
  14. Lypholization
  15. By NC Bionetwork
  16.  
  17. VIDEOs
  18. Bioprocessing Part 2 - Separation and Recovery (11 mins)
  19. Bioprocessing Part 3- Purification (20 mins)
  20. By NC Bionetwork
  21.  

 

 

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 
View File
File
Production Unit Overview for chapters 10-12 of Introdution to Biomanufacturing 
View File

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