Adoption is on the horizon
Continuous manufacturing has been established in several processing industries for many years, providing many benefits over batch manufacturing. The feasibility of continuous processing has now been shown for monoclonal antibodies (mAb) at both the process development (PD) and the production scales by early adopters.
Key Benefits of Continuous Manufacturing
Continuous processing offers several advantages over fed-batch in certain applications. Key advantages include:
- Increased flexibility to meet changing product demands
- Improved product quality and consistency
- Higher product output in a smaller footprint
- Reduced hold steps
- Increase in speed to production with plug and play equipment
- Reduced capital investment including the elimination of several buffer tanks, intermediate pool tanks and process skids
- Improved facility utilization and multi-product facility use
- Closed system operation
Continuous in Downstream
Until recently the adoption of continuous approaches in bioprocessing has been limited to perfusion cell culture with downstream processing unit operations and formulation taking place in batch mode. In this scenario, downstream processing still has capacity limitations and becomes a bottleneck for processing. Lately however, there has been an increased focus in the development of continuous processing solutions for downstream processing.
With the goal of developing a completely integrated end-to-end continuous processing platform, Pall Life Sciences launched their Cadence™ continuous portfolio of products. The Cadence line provides enabling technology for key downstream unit operations for continuous manufacturing of monoclonal antibodies and other recombinant proteins.
Key components of the Cadence continuous portfolio include:
- Cadence Acoustic Separator
Ideal for continuous removal of CHO cells and cell debris using a single-use acoustic chamber to achieve clarification of harvested cell culture fluid, ready for downstream processing.
- Cadence Inline Concentrator
A holder-less single-pass tangential flow filtration device with a retentate flow restrictor. It can be implemented in biotech DSP processes for continuous processing or in-process volume reduction for savings in time and cost.
- Cadence BioSMB PD System
A disposable flow path, continuous multi-column chromatography PD solution that is fully scalable to cGMP Manufacturing.
- Cadence BioSMB Process System
A disposable flow path continuous multi-column chromatography system designed to purify the clarified harvest from fed batch bioreactors of up to 2000 L working volume within 24 h under cGMP, featuring 8 columns to enable process flexibility and efficiency.
- Cadence Inline Diafiltration
Diafiltration is often perceived as a bottleneck in the purification process. The Cadence Inline Diafiltration system simplifies the process by eliminating the requirement for the recirculation and dilution procedures widely practiced with conventional TFF.
A fully continuous process is now possible
With the development of specific enabling continuous technology combined with the benefits of single-use approaches the biopharm industry can move towards integrated end-to-end continuous bioprocessing. Implementing continuous bioprocessing offers biopharmaceutical manufacturing a new business model and for many applications could result in lower costs, higher productivity, greater flexibility and tighter controls all within a much smaller facility footprint than traditional fed-batch.
To read case studies about continuous processing and associated applications, please download this eBook, “Is Continuous Bioprocessing the Future?”
To learn how Pall’s Continuous Ready products and integration expertise are making continuous bioprocessing a reality, please see following video