Technological progresses in monoclonal antibody production systems.

Area of Science:

• Biopharmaceutical Manufacturing
• Biotechnology
• Cell Culture Technology

Background:

• Monoclonal antibodies (mAbs) are vital biopharmaceutical products requiring large-scale production.
• High clinical doses necessitate increased biomanufacturing capacity, with mammalian cell culture being the dominant system.
• Optimizing cell culture productivity within existing bioreactors is a key strategy to meet demand.

Purpose of the Study:

• To review technological advancements in bioreactor systems for monoclonal antibody (mAb) production.
• To present the advantages and limitations of various production systems.
• To suggest improvements for enhancing mAb manufacturing processes.

Main Methods:

• Review of current and emerging bioreactor technologies for adherent and suspension cell cultures.
• Analysis of strategies for controlling culture parameters, including on-line multiparameter monitoring.
• Evaluation of disposable reactor systems and their growing interest.

Main Results:

• Emergence of new and upgraded bioreactors, including disposable options, for diverse cell culture types.
• Evolution of sophisticated control strategies for culture parameters, enabling real-time monitoring.
• Focus on improving productivity and economic viability in mAb manufacturing.

Conclusions:

• Technological progress in bioreactors and control systems is driving more efficient mAb production.
• Enhanced biomanufacturing processes aim to reduce costs and improve market accessibility of mAb therapies.
• Continuous innovation is essential for meeting the growing demand for monoclonal antibodies.