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Investigating a Bag Bioreactor System. Monoclonal Antibody Production. Angelica Bitton · Alain Laplume · Allison Turner. Overview. Process Overview Single-Use Bioreactors Model Manipulation Findings Sizing & Selection Cost Analysis Conclusions & Recommendations. Process Overview.
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Investigating a Bag Bioreactor System Monoclonal Antibody Production Angelica Bitton · Alain Laplume · Allison Turner
Overview Process Overview Single-Use Bioreactors Model Manipulation Findings Sizing & Selection Cost Analysis Conclusions & Recommendations
Process Overview Bag Bioreactor System (BBS-102)
Single-Use Bioreactors AAA Used in inoculation stages or pilot-plant scale fermentation steps LDPE liner or bag housed by stainless steel unit Agitation achieved by rocking mechanism or magnetic stirrer Reduced cleaning & sterilization requirements Reduced validation requirements Increased flexibility in design
Model Manipulation • Initial Conditions • Operating temperature: 37°C • Holding time: 120 minutes • Broth feed: 58.5 kg/batch • Capacity: 5 x 100 L bags • Inoculation medium solution: 175.4 kg/batch • Final mAb yield: 19.2 kg/batch • Manipulated Parameters • Temperature, holding time, broth feed • Bag capacity • Inoculation medium solution
Findings AAA Capacity: 2 x 100 L bags Inoculation medium solution: 22.5 kg/batch Final mAb yield: 19.0 kg/batch
Sizing & Selection • XDR Xcellerex Disposable series • Conventional SS vessel with LDPE insert • Magnetic stirring mechanism • Sartorius BIOSTAT® CultiBag RM line • LDPE bags housed by SS skid • Rocking stirring mechanism • GE Healthcare Wave bag bioreactor systems • SYSTEM200: 2 x 100 L • Operation under perfusion possible • Rocking stirring mechanism
Costing AAA • No vendor quotes available • According to GE Healthcare • Capital cost = 30% conventional SS bioreactor • Operating costs = 1/3 conventional SS bioreactor • SuperPro2008 estimated costs Calculated Costs • Bag bioreactor housing system • $165,000.00 • Capital equipment cost per batch • $600.00 ($300.00 per 100 L bag) • Utilities • Meaningful estimate not feasible • First 3 years • $202,800.00
Conclusions & Recommendations Single-use technology significantly reduces cost, validation, and cleaning requirements Reduction of media solution allows specified mAb yield of 19.0 kg/batch to be met with only 2 bags GE Healthcare Wave SYSTEM200 bag bioreactor system will meet the specific needs of this process Future investigations should assess the effect of holding time on the cell density & process yield
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