A common framework for integrated and continuous biomanufacturing.

Area of Science:

• Biopharmaceutical Manufacturing
• Biotechnology
• Process Engineering

Background:

• Integrated and continuous bioprocessing (ICB) is increasingly used for manufacturing recombinant protein therapeutics from mammalian cells.
• Existing ICB platforms show significant diversity, suggesting a need for standardization.
• A common framework for ICB could enable global manufacturing ecosystems and streamline regulatory processes.

Purpose of the Study:

• To review current and emerging ICB applications in Good Manufacturing Practice (GMP) settings for recombinant protein production.
• To discuss the adaptation of various ICB modes to a common framework, including their advantages and disadvantages.
• To provide a roadmap for ICB implementation strategies and equipment design.

Main Methods:

• Review of existing literature and industry practices regarding ICB for mammalian cell-based protein production.
• Analysis of the common framework's adaptability to different ICB modes and legacy processes.
• Description of equipment utilized within the common ICB framework.
• Case study of an example plant demonstrating flexibility and scalability.

Main Results:

• A common framework for ICB has emerged, facilitating manufacturing across diverse global sites with simple equipment.
• This framework supports most major biopharmaceutical ICB and legacy processes with minimal regulatory changes.
• An example plant demonstrates the framework's flexibility, handling batch sizes from 0.5 kg to 500 kg with a yearly output up to 8 tons.

Conclusions:

• The common ICB framework promotes manufacturing convergence and standardization in the biopharmaceutical industry.
• Adaptation to this framework offers significant advantages for companies and contract manufacturers.
• The described framework and example plant provide a practical guide for ICB implementation and equipment development.