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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
88% 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 


Outcomes and Impacts

The development of a closed design cell culture perfusion system will provide the industry with a fully controllable, scalable, and intensified solution that enables continuous biomanufacturing.

This new platform will improve manufacturing performance, reduce costs, increase product quality, and ensure greater regulatory compliance.

The project aims to implement an intensified continuous biomanufacturing platform, produce an economically optimized perfusion operation in a production bioreactor, demonstrate advanced control of productivity and CQA during specific stages of continuous operation, and create a prototype perfusion system for future cGMP implementation.

These goals will be accomplished through the platform’s design, which will reduce media consumption, increase cell and biologic yields, automate control of biotherapeutic product yield and quality attributes, and decrease the usage of raw materials for downstream processing.

Updates, Related Publications, and Deliverables

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Project Lead

University of Massachusetts System

University of Massachusetts System

Participating Organizations

Massachusetts Institute of Technology

Massachusetts Institute of Technology

Massachusetts Life Sciences Center

Massachusetts Life Sciences Center

Pfizer, Inc.

Pfizer, Inc.

Whirlcell LLC.

Whirlcell LLC.

Yokogawa Corporation Of America

Yokogawa Corporation Of America

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