Designing an Autonomous Integrated Downstream Sequence From a Batch Separation Process - An Industrial Case Study

Area of Science:

• Biochemical Engineering
• Process Chemistry
• Downstream Processing

Background:

• Industrial bioseparations traditionally rely on batch processing, leading to inefficiencies.
• Integrating multiple separation steps can streamline production and reduce resource utilization.
• Automation in downstream processing is crucial for enhancing efficiency and consistency.

Purpose of the Study:

• To present a proof of concept for an integrated autonomous downstream process.
• To demonstrate the conversion of sequential batch separation steps into a continuous flow process.
• To showcase the automation of a multi-step purification train.

Main Methods:

• The study integrated anion chromatography, virus inactivation, and hydrophobic chromatography.
• Operating points and separation data were extracted from batch chromatograms for integration.
• An ÄKTA Pure system controlled by Orbit software facilitated the complex process configuration.

Main Results:

• The integrated process successfully minimized hold-up times, storage tanks, and equipment requirements.
• A method for converting batch operations to an integrated, automated system was established.
• The proof of concept validated the principle of automated, multi-step downstream processing.

Conclusions:

• The integration and automation of sequential batch separation steps create a more efficient downstream process.
• This approach offers a pathway towards continuous biomanufacturing.
• The developed method enables complex process configurations for enhanced bioprocessing.