Scalable and Flexible Manufacturing
中文
中文
We employ a Scale-Plus manufacturing model, combining parallel operation of multiple single-use bioreactors with pooled downstream processing to ensure scalability and consistency.
Five 2,000 L Cytiva single-use bioreactors are operated in parallel under identical conditions, delivering up to 10,000 L total culture volume per batch. Harvested supernatants are pooled prior to purification, forming a single, homogeneous drug substance batch.
This approach integrates process robustness, product consistency, and operational flexibility, providing an efficient and scalable solution for commercial biologics manufacturing.
Parallel bioreactor operation enables rapid, linear scale-out without traditional scale-up risks
Production capacity can be flexibly adjusted to meet changing demand
Accelerates timelines from development to commercial manufacturing
Automated systems ensure tight control of critical parameters (pH, DO, temperature)
PAT-enabled real-time monitoring across all reactors
High comparability in cell performance, expression levels, and product quality ensures batch homogeneity
Eliminates scale-up uncertainties associated with traditional stainless steel systems
Single-use technologies minimize contamination risk and remove the need for CIP/SIP
Lower operational costs and improved facility utilization for multi-product manufacturing
