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Peptide Bioprocessing Scale-Up

Case Study

A development-stage pharmaceutical company engaged Nexus Bioworks to support the scale-up of a fermentation-derived peptide intended for use as an oral antibiotic.

Our client’s process was developed to a 10 L scale and required support to scale both the upstream and downstream processes to a 1,200 L scale to create enough material for use in pre-clinical toxicology studies.

Our client required not only support with process scale-up but also development of batch manufacturing records within a robust quality management system to support future scale-up work.

Nexus Bioworks applied its deep expertise in microbial fermentation and downstream purification to advance the client’s early-stage process into a robust, scalable bio-process.

Client Goals

  • Scale an established fermentation process from 1,400 L to 3,000 L manufacturing scale.
  • Tech transfer the current development scale process (10 L) to a cGMP facility for scale-up, the Nexus BioWorks facility for process optimization.
  • Development of a suitable downstream processing protocol suitable for a cGMP facility.
  • Tech transfer of analytical methods (Quantitative HPLC) for in-process and final product analysis.
  • Reproducible manufacture of the peptide at a 1,200 L scale.
  • Development of lyophilization cycle for the drug substance.

 

Market SectorPharmaceutical
Product TypePeptide
Expression StrainStreptococcus
Service OverviewProcess characterization and scale-up of a bioprocess for the manufacture of a lyophilized drug substance for use in pre-clinical studies
Final FormatLyophilized Powder
Final Scale1,200 L

Nexus Approach

Generation of documentation including overarching project plan, technical transfer protocols, and batch manufacturing documentation.

The 10 L upstream bioprocess was replicated at the Nexus Bioworks facility to ensure reproducible results prior to optimization.

The upstream process was optimized and scaled up from 50 L, then further scaled up to 1,200 L to support larger-scale production.

Development of a customized four-step purification process combining ion exchange and affinity chromatography, alongside establishment of new and transferred HPLC methods for in-process control and final QC.

Development of a lyophilization cycle suitable for the production of bulk lyophilized powder.

Peptide Bioprocessing Scale-Up Overview

Overview of the client’s bioprocess workflow, outlining the distinct stages of the upstream and downstream processes.

 

Project Delivery Milestones

To achieve the clients’ goals, Nexus Bioworks broke the project down into the following smaller work packages that acted as distinct project milestones. The timeline for full project completion was two years.

Work Package 1:

  • Technical transfer of development scale process
  • Transfer of HPLC analytical method
  • Process characterization at a 10 L scale
  • Process definition and documentation

 

Work Package 2:

  • Development of in-process and final QC HPLC methods
  • Process optimization – 50 L scale
  • Downstream processing optimization

Work Package 3:

  • Process optimization at 1,200 L scale
  • Lyophilization cycle development

 

Work Package 4:

  • 1,200 L scale manufacture of bulk drug substance
  • 3 x process validation batches manufactured

Project Highlights

Nexus Bioworks worked closely with the client to transfer a developmental-scale process into the Nexus Bioworks facility and perform controlled and concise scale-up.

We worked closely with the client to understand their process constraints and created a comprehensive work plan to meet their objectives.

Over two years, the Nexus Bioworks team characterized, optimized, defined, and scaled the client’s biomanufacturing process from 10 L to 1,200 L, successfully producing material for preclinical toxicology studies.

 

Key Metrics:

  1. Developed a harvest process for peptide recovery from fermentation broth
  2. Designed a four-step ion exchange and affinity chromatography purification workflow
  3. Optimized upstream processing for a demanding microbe requiring controlled exponential feed rates
  4. Established HPLC methods for in-process and final product quality control

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Upstream ProcessingDownstream PurificationAnalytical TestingFormulation & Final Product Processing

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PartneringExperienceAnaerobic FermentationE. coli FermentationPeptide Bioprocessing

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