Downstream Processing

1. The Downstream Processing unit of the NBC2 global biomanufacturing curriculum provides curricular material for each step of the downstream purification process for a biotheraputic, starting with the bioreactor harvest pool and finishing with pre-formulation drug substance.

2.  
3. introduction to biomanufacturing TEXTBOOK CHAPTER

4. Chapter 11: Downstream Processing

5. Production Unit Overview
6.  
7. Protein Purifications

• ANTI-IL8 MONOCLONAL ANTIBODY, mAb

• ⇰ FLOW CHART: mAb Downstream Process   

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• Tangential Flow Filtration

• ⇰ End of Run anti-IL8 mAb Process: Harvest, Centrifugation, TFF Concentration SOP
• ⇰ BATCH RECORD: for Downstream Processing of Anti-IL8 mAb
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• ÄKTA Purification System
• ⇰ USER GUIDE: AKTA pure 25 User Introduction
• ⇰ Operation of ÄKTA pure Chromatography System SOP
• ⇰ Isolation of mAb (Anti-IL8) from Conditioned Medium by Protein A Affinity Chromatography on the AKTA pure Chromatography System SOP
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• BioRad Biologics LP Purification System
• ⇰ BATCH RECORD: Downstream Process Isolation of Anti-IL8 mAb from CHO Cells: Chromatography Operation
• ⇰ Biologic LP Chromatography System Operation SOP
• ⇰ Isolation of Anti-IL8 mAb by Protein A Affinity Chromatography on the Bio-Rad Biologic LP Chromatography System SOP
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• Virtual learning module for Downstream Processing of mAbs
• mAb Downstream Processing
• Virtual Tools for Protein Purification and Downstream Processing Webinar
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• TISSUE PLASMINOGEN ACTIVATOR, tPA
• ⇰ Downstream Process Flow-Chart for tPA
• ⇰ End-of-Run tPA Process: Harvest, Centrifugation, pH Adjustment SOP
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• ÄKTA Purification System
• ⇰ Batch Record: tPA Production from CHO Cells AKTA Pure Chromatography Operation
• ⇰ USER GUIDE: AKTA pure 25 User Introduction
• ⇰  ÄKTA pure Operation SOP
• ⇰ Cation Exchange Chromatography of tPA using the AKTA Pure System SOP
• ⇰ Lysine Affinity Chromatography of tPA on the AKTA Pure System SOP
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• BioRad Biologics LP Purification System
• ⇰ Batch Record: tPA Production from CHO Cells Downstream Process Biologics LP System
• ⇰ Ion Exchange Chromatography of tPA on the Biologics LP System SOP
• ⇰ Biologic LP Chromatography System Operation SOP

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GREEN FLUORESCENT PROTEIN, GFP

⇰ Preparation of Bacterial Cell Lysate using B-PER Reagent SOP

• ÄKTA Purification System

• ⇰ Anion Exchange Chromatography of Green Fluorescent Protein (GFP) using the AKTA Pure System SOP
• ⇰ USER GUIDE: AKTA pure 25 User Introduction
• ⇰ ÄKTA pure Operation SOP
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• BioRad Biologics LP Purification System
• ⇰ BioLogic LP HIC Chromatography of GFP SOP
• ⇰ Biologic LP Chromatography System Operation SOP
• ⇰ Anion Exchange Chromatography of Green Fluorescent Protein (GFP) using the Biologics LP System SOP
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• IMAC Affinity Purification of GFP
• ⇰ Purification of His-tag GFP using Immobilized Metal Affinity Chromatography SOP
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• HUMAN SERUM ALBUMIN, HSA
• Tangential Flow Filtration
• ⇰ Tangential Flow Filtration of HSA Process SOP
• ⇰ Millipore Tangential Flow and Diafiltration Using Pellicon XL Device SOP
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• ⇰ Batch Record: HSA Production from Pichia pastoris Downstream Processing Affinity Chromatography of HSA SOP

Associated Quality Control Biochemistry SOPs can be found on the Quality Control Biochemistry page.

1. SKILL STANDARDS

2. Downstream Processing Skill Standards

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5. Introduction to Biomanufacturing Master Glossary

1. OTHER RESOURCES:
2. Virtual Labs
3. Virtual Tour of a Biomanufacturing Facility
4. By Amgen
5.  
6. Biomanufacturing e-Learning Resources
7. Chromatography
8. By NC Bionetwork
9.  
10. VIDEOs
11. Bioprocessing Part 2 - Separation and Recovery (11 mins)
12. Bioprocessing Part 3- Purification (20 mins)
13. By NC Bionetwork
14.