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.
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:
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.
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