Protein Expression Services and Strain Development

Get early, actionable insight into expression performance and scalability

We help you move from construct to purified protein quickly and with confidence. By combining deep expertise in microbial systems, particularly E. coli and L. Lactis, we identify the optimal strain and expression strategy tailored specifically to your protein and downstream goals.

From the very beginning, we evaluate expression levels, solubility, and cellular localization to give you critical insight into manufacturability and scalability.

This allows you to make informed decisions early, reduce development risk, and avoid costly surprises later.

Our fully documented, tech-transfer ready processes are designed for seamless transfer to your preferred CMO, giving you a strong and scalable foundation for clinical and commercial manufacturing.

Building on this foundation, our processes are fully documented and tech-transfer ready, providing a robust basis for transfer to your preferred CMO for API manufacturing when required.

In parallel, we offer in-house GMP-grade manufacturing of non-API proteins, including proteins used in cell and gene therapy manufacturing, diagnostics, and biosolutions. Our processes are designed to support seamless progression to pilot scale while maintaining scalability and regulatory readiness.

Lasse Pedersen, protein expression services
Protein expression, Lasse Pedersen

Expression Capabilities

  • Expression systems: E. coli, L. lactis, or your preferred system
  • Parallel screening of constructs and expression conditions
  • Purified protein in as little as 7 weeks
  • Gram-scale production
  • Development of Research Cell Banks

What you can expect

  • Early de-risking of your development program
  • Transparent timelines and clear communication
  • Scalable, tech-transfer ready processes
  • A partner experienced in taking proteins from research to manufacturing

Expression Capabilities

  • Expression systems: E. coli, L. lactis, or your preferred system
  • Parallel screening of constructs and expression conditions
  • Purified protein in as little as 7 weeks
  • Gram-scale production
  • Development of Research Cell Banks

What you can expect

  • Early de-risking of your development program
  • Transparent timelines and clear communication
  • Scalable, tech-transfer ready processes
  • A partner experienced in taking proteins from research to manufacturing
Protein expression, Lasse Pedersen

Workflow at Bioneer

Leveraging our expertise across diverse protein types and our comprehensive protein expression services, we provide early insights into the expression of your protein. We mitigate risk through a flexible step-wise project approach with Go/No-Go decision points.

Below you get an overview of our typical workflow.

Process Step

Our approach

Time

Gene Design and Plasmid Preparation
  • Gene sequence is optimized for use in selected system
  • Gene synthesis via 3rd party provider
  • Cloning into expression vector and transformation of expression strain.
2 – 4 weeks
Strain Selection and Banking
  • Screen up to 72 constructs in parallel using deep well plates
  • Test of various strains, plasmids, and genetic constructs
  • RCB banking
2+ weeks
Feasibility Studies
  • Test expression in shake-flasks (30 mL – 100 mL)
  • Test of various expression conditions
  • Analysis via SDS-PAGE, western blotting
2 – 3 weeks

Report Outlining Expression Results (Go/No Go)

Upscaled Expression in Shake-Flasks
  • Upscaled expression of selected constructs
  • Up to 5 L culture volume can be expressed in parallel using shake-flasks
2 – 3 weeks
Batch and Fed-batch Production & Upstream Process Development
  • Standardized batch and fed-batch production processes
  • Development of Customized processes
  • 6x 1 L glass fermentors
  • 1x 15 L stainless steel fermentor
  • 4x 50 L dedicated steel fermentors for manufacturing
2+ weeks

Reporting & Delivery of Culture Supernatant/Cell Pellets/Inclusion Bodies (Go/No-Go)

Purification and Downstream Process Development
  • Affinity purification for rapid delivery of purified product
  • Development of a downstream process customized for your protein
  • Inclusion Body isolation, solubilization and refolding
2+ Weeks
Characterization and Analysis
  • Customized analytical packages leveraging a full range of protein characterization methods
2+ Weeks
Formulation
  • Stability studies, buffer optimization, and more to create the optimal formulation for your protein
2+ Weeks

Reporting and Delivery of Purified Protein

Our Recombinant Protein Leadership:

  • Søren Madsen, Protein Expression, Dept. Head, Ph.D
Søren Madsen, Protein expression, Dept. Head, Ph.D

Workflow at Bioneer

Leveraging our expertise across diverse protein types and our comprehensive protein expression services, we provide early insights into the expression of your protein. We mitigate risk through a flexible step-wise project approach with Go/No-Go decision points.

Below you get an overview of our typical workflow.

Our Process and Approach

Our Approach:

Gene sequence is optimized for use in selected system

Gene synthesis via 3rd party provider

Cloning into expression vector and transformation of expression strain.

Time: 2-4 Weeks

Our Approach:

Screen up to 72 constructs in parallel using deep well plates

Test of various strains, plasmids, and genetic constructs

RCB banking

Time: 2+ Weeks

Our Approach:

Test expression in shake-flasks (30 mL – 100 mL)

Test of various expression conditions

Analysis via SDS-PAGE, western blotting

Time: 2-3 Weeks

Report Outlining Expression Results (Go/No Go)

Our Approach:

Upscaled expression of selected constructs

Up to 5 L culture volume can be expressed in parallel using shake-flasks

Time: 2-3 Weeks

Our Approach:

Standardized batch and fed-batch production processes

Development of Customized processes

6x 1 L glass fermentors

1x 15 L stainless steel fermentor

4x 50 L dedicated steel fermentors for manufacturing

Time: 2+ Weeks

Reporting & Delivery of Culture Supernatant/Cell Pellets/Inclusion Bodies (Go/No-Go)

Our Approach:

Affinity purification for rapid delivery of purified product

Development of a downstream process customized for your protein

Inclusion Body isolation, solubilization and refolding

Time: 2+ Weeks

Our Approach:

Customized analytical packages leveraging a full range of protein characterization methods

Time: 2+ Weeks

Our Approach:

Stability studies, buffer optimization, and more to create the optimal formulation for your protein

Time: 2+ Weeks

Reporting and Delivery of Purified Protein

Our Recombinant Protein Leadership:

  • Søren Madsen, Protein Expression, Dept. Head, Ph.D
Søren Madsen, Protein expression, Dept. Head, Ph.D

Contact us for a free consultation

Interested in learning how we can support your project or pipeline?

We´re always happy to chat.

ryan polito expression services and stran development

For further information please contact Sr. Business Development Manager Ryan Polito on rpo@bioneer.dk or  +4551443005