html5-img
1 / 10

Monoclonal Antibody Production

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.

myron
Download Presentation

Monoclonal Antibody Production

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Investigating a Bag Bioreactor System Monoclonal Antibody Production Angelica Bitton · Alain Laplume · Allison Turner

  2. Overview Process Overview Single-Use Bioreactors Model Manipulation Findings Sizing & Selection Cost Analysis Conclusions & Recommendations

  3. Process Overview Bag Bioreactor System (BBS-102)

  4. 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

  5. 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

  6. Findings AAA Capacity: 2 x 100 L bags Inoculation medium solution: 22.5 kg/batch Final mAb yield: 19.0 kg/batch

  7. 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

  8. 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

  9. 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

  10. THANK YOU QUESTIONS?

More Related