The design basis for the integrated and continuous biomanufacturing framework.

Area of Science:

• Biopharmaceutical Manufacturing
• Chemical Engineering
• Biotechnology

Background:

• Traditional biopharmaceutical manufacturing relies on large-scale fed-batch processes.
• Existing facilities often require significant capital investment and space.
• There is a need for more flexible and efficient biomanufacturing platforms.

Purpose of the Study:

• To describe a novel 8-ton per year integrated and continuous bioprocessing (ICB) facility.
• To provide detailed design specifications for biopharmaceutical companies, vendors, and contract manufacturers.
• To enable the transformation of biopharmaceutical manufacturing through a global ICB ecosystem.

Main Methods:

• Framework for integrated and continuous bioprocessing (ICB).
• Utilized four 2000 L single-use bioreactors.
• Maximum flow rate of 13 L/min.

Main Results:

• Facility output rivals large fed-batch plants despite smaller equipment footprint.
• Achieved production scale from 10 g to 35 kg of drug substance per day.
• Design is backward compatible with legacy fed-batch processes.

Conclusions:

• The described ICB facility design offers a scalable and efficient alternative to traditional biomanufacturing.
• This design facilitates the creation of a global ICB ecosystem, revolutionizing drug substance production.
• The system supports both clinical and commercial scale production with adaptable batch sizes.