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Fully integrated downstream process to enable next-generation manufacturing.

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Next-generation manufacturing (NGM) offers significant cost and time savings for biopharmaceutical production. A new integrated system automates continuous purification, enabling efficient, long-term monoclonal antibody processing.

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Engineering
  • Automation and Control

Background:

  • Large biopharmaceutical organizations are increasingly investing in Next-Generation Manufacturing (NGM) technologies.
  • NGM implementation is driven by the need for reduced costs, shorter timelines, and enhanced capabilities.
  • Traditional batch manufacturing processes present limitations in efficiency and scalability.

Purpose of the Study:

  • To demonstrate productivity improvements in biopharmaceutical purification using an integrated and automated NGM system.
  • To evaluate the feasibility and benefits of a turn-key continuous purification system compared to custom integration.
  • To present the process fit, control strategies, and automation features enabling long-term continuous operation.

Main Methods:

  • Utilized a turn-key automated and integrated system capable of simultaneous continuous purification stages.
  • Implemented new automation strategies, including pH feedback control and in-line detergent addition.
  • Conducted a 14-day end-to-end monoclonal antibody purification process at clinical manufacturing scale.

Main Results:

  • Achieved significant cost benefits (~10x lower) compared to traditional equipment integration.
  • Demonstrated robust linking of unit operations through advanced automation strategies.
  • Successfully enabled continuous operation with effective sterility and bioburden control.

Conclusions:

  • Integrated and Continuous Biomanufacturing, facilitated by automated systems, offers substantial reductions in facility size and manufacturing costs.
  • NGM systems provide enhanced product quality and operational flexibility compared to batch processing.
  • The presented system offers a viable and cost-effective solution for implementing NGM in biopharmaceutical production.