Large scale industrialized cell expansion: producing the critical raw material for biofabrication processes

Area of Science:

• Biotechnology
• Regenerative Medicine
• Cellular Engineering

Background:

• Cellular biomanufacturing is crucial for advancing regenerative therapies, organ-on-chip models, and disease research.
• Producing sufficient quantities of living cells is a primary challenge for biofabrication processes like bioprinting.
• Anchorage-dependent cells require specific conditions for large-scale expansion.

Purpose of the Study:

• To review cell expansion bioreactor principles for industrial-scale cellular biomanufacturing.
• To highlight the role of 3D culture in achieving high-yield cell production.
• To identify challenges in cellular biomanufacturing concerning Good Manufacturing Practices (GMP).

Main Methods:

• Review of cell expansion bioreactor operating principles.
• Analysis of 3D culture techniques for anchorage-dependent cell proliferation.
• Discussion of challenges in meeting GMP standards for cellular products.

Main Results:

• 3D culture systems are vital for producing billions to trillions of anchorage-dependent cells.
• Biofabrication technologies offer improved 3D surfaces for industrialized cell production.
• Key challenges include ensuring safety, purity, stability, potency, and identity in cell manufacturing.

Conclusions:

• Optimizing bioreactor operation and 3D culture is key to meeting demand for cellular therapies.
• Addressing GMP compliance is critical for the successful translation of cellular biomanufacturing.
• Biofabrication advancements are essential for the industrial-scale production of living cells.