Integrated Continuous USP Platform for Maximum Productivity and Closed-loop controlled CQA

Development of a entirely closed cell culture perfusion system that (1) reduces media consumption, (2) provides higher cell & biologic yields, and (3) automates control methods of productivity and Critical Quality Attributes.
Categories
Cell and Gene therapies
Drug substance
Process control
Project status
100% Completed

Industry Need

Biotherapeutic manufacturing has been improved significantly in terms of productivity and controllability of Critical Quality Attributes (CQA), but fully controllable, scalable, and intensified biomanufacturing is still a distance target. 

  • Perfusion-based continuous manufacturing has been demonstrated as a new platform but still poses a few challenges:  
  • Excessive usage of media  
  • Lack of fully automated control methods for CQA and productivity 
  • Suboptimal scale-up and operation 
  • Because of these challenges, perfusion-based production has been limitedly applied, and mostly in N-1 bioreactors with VCD as a controlled variable. 
  • Perfusion cell-culture has been explored for decades, but its potential has been unrealized due to issues with practical implementation and cost.


Solution

The University of Massachusetts Lowell (UML) and team are developing and validating a mammalian cell culture system with an integrated continuous USP platform for maximum productivity and closed-loop control of CQA.  The new intensified biomanufacturing platform will deliver: 

  • Scalable perfusion-based continuous production  
  • Optimal media usage through economically optimized perfusion operation  
  • Automated control methods of productivity and CQA during specific stages of continuous operation 


Outputs/Deliverables

1.Microfluidic cell retention device building

2.Integration of hardware and software system

3.Perfusion system with media recycle

4.Utilize EK filter for separating lactate and product while retaining most media components

5.Demonstration of CHO productivity and CQA control implementation

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