Downstream Bioprocessing: It’s Time to Get Connected 

Advances in upstream processes don’t fully translate into overall productivity gains due to issues further downstream. But help is at hand — a connected downstream process can be a game-changer. 

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The biopharma industry has optimized upstream production processes. But downstream process advances haven’t kept up, creating bottlenecks that stifle the value and efficiency offered by gains upstream.  

The main challenges in downstream production (DSP) are low productivity, high footprint, and high equipment downtime — all of which impact cost of goods and annual facility output. And manufacturers need to keep production scalable and flexible to adapt to changing and expanding product pipelines. 

For manufacturers looking to intensify DSP while maintaining scalability and flexibility, a connected process can provide the solution.

What is a connected process? 

Put simply, a connected process is an integrated approach to the purification and processing of a biopharmaceutical product to raise productivity and lower costs.  

Traditionally, there has been a step-by-step batch approach that uses different unit operations — harvest and clarification, capture, viral inactivation, further purification and polishing, virus filtration, and concentration and diafiltration.  

But in a connected process, multiple-unit operations are connected in series and run parallel to each other with minimal interruption. This increases efficiency while reducing processing time.

Implementing connected DSP: Enzene Biosciences case study 

Developing and scaling up a connected DSP platform requires the right technology and support. It also needs a clear proof of concept that shows benefits for productivity, efficiency, and quality data.   

Sartorius has the expertise in process and equipment design, process development and validation, and regulatory support needed to change a process or develop a new facility design. This was demonstrated in our collaboration with Enzene Biosciences, where we built an end-to-end platform process that enabled connected processing for monoclonal antibodies using Sartorius chromatography media.

A platform for progress 

For the platform, we focused on choosing chromatography media that would enable connectivity between operations without compromising yield and quality. We designed and implemented the process using three key technologies: 

• Resolute^® BioSC multi-step chromatography system for purification 

• Sartobind^® Q strong ion exchangers for polishing and purification 

• CMM Hypercel cation exchange resin for polishing and purification  

The platform leverages the highly modular Resolute^® BioSC Pilot to operate and connect these multiple steps under a single automation umbrella. Ultimately, the collaboration delivered a seamless transition from batch to connected downstream process with impressive results: 

• 35% time-savings per batch 

• 2-3X lower footprint 

• 16% additional annual capacity

Dig deeper 

To learn more about downstream bioprocessing optimization using a connected process, check out the recent GEN webinar that covers the Enzene case study in more detail. Here, project leaders Abijar Bhori from Enzene and Sanket Jadhav from Sartorius describe how they developed and scaled up their connected DSP platform while safeguarding quality, in addition to the value they discovered by switching from a batch proces.

Want to discuss how a connected process can work with your specific DSP needs? Fill out our contact form and one of our experts will be in touch soon.