P243: 14 Day Continuous Purification Process Achieves Acceptable Bioburden and Product Quality
Poster Presenter
Celeste Lee Amadei
Product Manager
PAK Biosolutions United States
Objectives
We sought to evaluate the product quality of a 14 day continuous purification process for monoclonal antibody production compared to the standard batch process.
Method
An automated, off-the-shelf continuous purification skid was used to process 2 different mAbs through dual-column protein A chromatography, low-pH viral inactivation, viral filtration, anion exchange, & 4 rounds of ultrafiltration/diafiltration matching a 50L/day perfusion bioreactor over 14 days.
Results
Bioburden remained below threshold for the entirety of the 14 day study. Acidification and neutralization for viral inactivation was achieved with sufficient residence time and tight PID control. Host cell protein and DNA were sufficiently below the threshold. Monomer purity was above the minimum limit after protein A chromatography. Automation reduced time and labor. Resin costs were reduced. Footprint was reduced by 60%.
Conclusion
Using the automated continuous purification skid for a 14 day process producing monoclonal antibodies offered multiple benefits over the standard batch process techniques. The product quality was equal to or better than the quality achieved using prior methods. Efficiency was increased while costs were decreased. Key concerns that have previously dampened efforts to switch to continuous processing, such as bioburden and viral clearance, were successfully addressed and overcome.
