EKF Diagnostics logo
  • Services 
    Back
    Services

    Learn more
    • Upstream Processing 
      Enable stepwise, risk-controlled scale up of microbial bioprocesses, from benchtop through to commercial scale fermentation with flexible capacity that grows alongside your program.
    • Downstream Purification 
      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.
    • Analytical Testing 
      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.
    • Formulation & Final Product Processing 
      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.
  • Experience
  • Partnering
  • About Nexus
  • EKF Diagnostics
  • Talk to our experts

Anaerobic Fermentation Scale-Up

Case Study

A research-focused pharmaceutical company engaged Nexus Bioworks to support the scale-up and routine manufacture of an extracellular enzyme used in tissue dissociation research and topical therapeutic applications.

The client had manufactured the product at a 1,400 L scale for many years and required increased production capacity to meet growing demand.

Leveraging decades of microbial fermentation expertise, Nexus Bioworks successfully scaled the process to 3,000 L and established a robust long-term manufacturing programme.

Client Goals

  • Scale an established fermentation process from 1,400 L to 3,000 L manufacturing scale.
  • Ensure consistent, high-quality manufacture of biomaterial under controlled production conditions.
  • Transfer analytical methods for in-process product monitoring.
  • Establish a reliable and scalable manufacturing workflow capable of supporting increasing market demand.
  • Build a long-term partnership to support ongoing routine production and future process improvements.

 

Market SectorResearch / Pharmaceutical
Product TypeEarly-stage therapeutic extracellular enzyme used in topical formulations and tissue dissociation research.
Expression StrainClostridium histolyticum (Wildtype Anaerobe)
Service OverviewProcess scale-up from 1,400 L to 3,000 L and routine manufacture of product
Final FormatConcentrated Liquid
Final Scale3,000 L Routine Manufacture

Nexus Approach

Generation of project documentation including technical transfer protocols, manufacturing documentation, analytical method transfer plans and process scale-up strategy.

Routine manufacture established at the 1,400 L scale prior to process expansion. Scale-up of the anaerobic fermentation process to 3,000 L while maintaining product quality and reproducibility.

Transfer and implementation of spectrophotometric analytical methods for in-process monitoring and manufacturing control. Ongoing collaboration to support continual process optimization and manufacturing improvements

Anaerobic Fermentation Scale-Up Overview

Overview of the manufacturing workflow, illustrating the key stages of fermentation, product recovery and final formulation.

 

Project Delivery Milestones

To achieve the client's goals, Nexus Bioworks broke the project down into four distinct work packages that acted as key project milestones. The programme was completed over two years, culminating in successful scale-up and routine manufacturing at the 3,000 L scale.

Work Package 1:

  • Technical transfer of manufacturing process
  • Transfer of analytical assay for in-process testing
  • Process definition and documentation

 

Work Package 2:

  • Routine manufacture at 1,400 L scale
  • Process performance monitoring
  • Manufacturing consistency assessment

Work Package 3:

  • Scale-up of anaerobic fermentation process to 3,000 L
  • Process optimization at production scale
  • Verification of product quality and reproducibility

 

Work Package 4:

  • Routine manufacture at 3,000 L scale
  • Continuous process improvement activities
  • Long-term manufacturing support

Project Highlights

Nexus Bioworks worked closely with the client to transfer, define and scale an established anaerobic fermentation process for commercial manufacture.

Through a structured scale-up programme, production capacity was successfully expanded from 1,400 L to 3,000 L while maintaining product quality and process consistency.

The resulting manufacturing process continues to support routine production through a long-term collaborative partnership focused on quality, reliability and continuous improvement.

 

Key Metrics:

  1. Successfully scaled a spore-forming anaerobic fermentation process from 1,400 L to 3,000 L manufacturing scale
  2. Established routine commercial manufacture of enzyme product at a 3,000 L scale while maintaining consistent quality standards
  3. Transferred and implemented spectrophotometric analytical methods to support in-process product monitoring and manufacturing control
  4. Established a long-term manufacturing partnership supporting continuous process optimisation and operational improvement

Partner with Nexus Bioworks for scalable microbial biomanufacturing

Talk to our experts
Level AAA conformance, W3C WAI Web Content Accessibility Guidelines 2.2

Services

Upstream ProcessingDownstream PurificationAnalytical TestingFormulation & Final Product Processing

Partnering

PartneringExperienceAnaerobic FermentationE. coli FermentationPeptide Bioprocessing

About

ContactAboutESG StatementModern Slavery Statement

Other

Accessibility StatementPrivacy PolicyCookie PolicyTerms & Conditions
Level AAA conformance, W3C WAI Web Content Accessibility Guidelines 2.2

© 2026 EKF Diagnostics Holdings plc. All rights reserved.