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Enable stepwise, risk-controlled scale up of microbial bioprocesses, from benchtop through to commercial scale fermentation with flexible capacity that grows alongside your program.
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Deliver target yield, purity, and performance through custom downstream solutions, engineered to align with your specifications and optimize every stage of your process for consistent, reliable results.
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Ensure confidence at every stage with structured, risk-managed transfer, qualification, and validation of analytical assays for raw material inspection, in-process analysis, and final product release.
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Streamline production with integrated formulation, bulk lyophilization, and fill-finish services, enabling efficient progression from pilot batches to high-volume output with consistent quality and reliability.
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EKF Diagnostics
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E. coli Fermentation Scale-Up

Case Study

A biotechnology company focused on enzyme-based anaerobic culture and specimen preservation solutions, engaged Nexus Bioworks to support the scale-up and routine manufacture of a key enzyme product.

Initially produced using a wild-type host, the process was successfully scaled to a 1,600 L manufacturing scale before transitioning to a recombinant E. coli expression system to improve manufacturing efficiency.

Leveraging extensive expertise in microbial fermentation, Nexus Bioworks supported process development, scale-up and long-term commercial manufacture of the product.

Client Goals

Transfer the manufacturing process from a 250 L scale into a regulated manufacturing environment.
Scale the optimized biomanufacturing process to a 1,600 L production scale.
Transition production from a wild-type host to recombinant E. coli to improve manufacturing efficiency.
Establish reliable routine manufacturing capability across varying production demands.
Maintain product quality and process consistency during scale-up and host transition activities.

Market Sector	Research and Industrial
Product Type	Enzyme used for the removal of oxygen from industrial and research processes
Expression Host	Recombinant E. coli
Service Overview	Process scale-up to 1,600 L, expression host transition, and routine manufacture
Final Format	Frozen Cell Paste
Final Scale	1,600 L

Nexus Approach

Generation of project documentation including technical transfer protocols, analytical method transfer plans and manufacturing documentation.

Transfer of the original manufacturing process into the Nexus Bioworks facility followed by scale-up to 1,600 L production scale.

Development and scale-up of a revised manufacturing process following transition to a recombinant E. coli expression system.

Establishment of routine manufacturing workflows, ongoing technical support and capacity flexibility to enable reliable commercial production.

E. coli Fermentation Scale-Up Overview

Overview of the manufacturing workflow, illustrating the key stages of fermentation, harvest and final product preparation.

Project Delivery Milestones

To achieve the client's goals, Nexus Bioworks divided the programme into five distinct work packages that acted as key project milestones. Delivered over a long-term partnership spanning more than 20 years, these activities enabled process scale-up, expression host transition and routine commercial manufacture.

Work Package 1:

Technical transfer of manufacturing process
Transfer of analytical methods
Process definition and documentation

Work Package 2:

Scale-up of manufacturing process to 1,600 L
Optimization of production batch documentation
Process verification activities

Work Package 3:

Routine manufacture at 1,600 L scale
Process performance monitoring
Ongoing manufacturing support

Work Package 4:

Transition from wild-type host to recombinant E. coli
Process development and optimization
Production-scale implementation

Work Package 5:

Routine manufacture using recombinant E. coli
Flexible scale-up and scale-down production support
Continuous process improvement

Project Highlights

Nexus Bioworks has partnered with the client for more than 20 years, supporting the manufacture, scale-up and ongoing optimisation of its oxygen-removal enzyme technology.

Through a structured development programme, the team successfully expanded manufacturing capacity to 1,600 L and later implemented a transition to a recombinant E. coli expression system.

The resulting process provides reliable supply, manufacturing flexibility and long-term operational support to meet evolving customer requirements.

Key Metrics:

Successfully scaled enzyme production from 250 L development-scale operations to routine manufacture at the 1,600 L scale
Developed and implemented a manufacturing process based on a recombinant E. coli expression system to improve production efficiency
Maintained critical dissolved oxygen control and fed-batch fermentation conditions to support consistent enzyme production
Provided manufacturing, troubleshooting and flexible capacity support through a collaborative partnership spanning more than 20 years

Partner with Nexus Bioworks for scalable microbial biomanufacturing

Talk to our experts

E. coli Fermentation Scale-Up

Case Study

Client Goals

Nexus Approach

E. coli Fermentation Scale-Up Overview

Project Delivery Milestones

Project Highlights

Partner with Nexus Bioworks for scalable microbial biomanufacturing

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