Scalability is a fundamental challenge in bioprocessing, particularly in cell culture-based manufacturing. As the demand for advanced therapeutics, including cell and gene therapies, continues to grow, manufacturers must choose between two primary strategies for increasing production capacity: scale-up and scale-out.

Cell culture systems are the foundation of modern biopharmaceutical production, playing a crucial role in advanced therapy medicinal products (ATMPs), viral vector manufacturing, and cell-based therapies. The decision between 2D and 3D cell culture impacts scalability, process robustness, and final product quality, making it essential for manufacturers to select the right approach.