Upstream Process Development

Efficient upstream process development is essential for achieving high-yield and scalable recombinant protein production.

At Bioneer, we develop and optimize cultivation processes for both mammalian and microbial expression systems, tailoring each workflow to your target protein, host cell line, and downstream requirements.

Through systematic optimization of cultivation parameters such as temperature, pH, and media composition, we identify robust conditions that maximize expression and support reliable scale-up.

Whether you need to establish a new upstream process, optimize an existing one, conduct confirmation runs, or prepare for larger-scale production, our team provides the expertise and infrastructure to move your project forward efficiently.

Why Bioneer?

With over 30 years of protein expertise, we offer a rapid project start-up and flexible solutions that adapt to your project needs.

Our robust and well-documented processes ensure reliable results, while our customized solutions make even the most complex projects manageable.

Based in the Medicon Valley, we combine the agility of a CRO/CDMO with the high-quality standards you expect from a Nordic partner.

Mammalian Upstream Process Development

Achieving optimal yield and product quality in mammalian protein expression requires careful optimization of cultivation conditions.

The upstream process plays a critical role not only in productivity, but also in shaping key product attributes such as post-translational modifications (PTMs), including glycosylation patterns that can impact efficacy, stability, and safety.

By adjusting parameters such as temperature, pH, feeding strategy, and nutrient composition, we design cultivation processes tailored to maximize production in your chosen mammalian cell line while supporting consistent product quality.

Our approach focuses on establishing upstream conditions that promote the desired quality profile alongside high expression levels.

Starting with small-scale experiments in tubes and shake flasks, we identify optimal expression conditions and evaluate how these influence both yield and critical quality attributes. Promising processes are then assessed for scalability using single-use bioreactors.

Whether you are developing a new process, optimizing an existing one, conducting confirmation runs, or producing material for pre-clinical studies, our expertise and infrastructure enable robust upstream processes that support both productivity and product quality.

Get our whitepaper on optimized fed-batch fermentation!

Upstream Process development

Key capabilities

  • Fed-batch, intensified fed-batch, and perfusion production
  • Increase yields up to 2-fold
  • 2 × 1 L or 2 × 10 L single-use bioreactors
  • Media and process optimization

Still Bioneer, Now Even Faster

–  With the Ambr®250 high-throughput bioreactor system

Building on our established upstream platform, we have recently expanded our capabilities with the Ambr® 250 system to further accelerate process development.

Hear from Christian Müller, PhD, Sr. Project Manager & Principal Scientist, and Alexandra Baer, PhD, R&D Manager, Mammalian Cell Line Development, as they explain how the Ambr® 250 enhances upstream development and de-risks scale-up for biologics production.

Microbial Upstream Process Development

We provide comprehensive assistance in upstream process development for microbial expression systems, covering both batch and fed-batch processes and preparing them for manufacturing.

Our expertise spans from conceptualization to scalable implementation, ensuring a smooth transition from laboratory to larger production volumes.

By tailoring cultivation conditions, we optimize protein expression in your microbial strain.

With the capability to scale up to 50 L in steel fermentors, we offer a robust platform for process validation, production scale-up, and manufacturing.

Whether you’re initiating process development, scaling up production, or conducting validation studies, our dedicated and experienced team is committed to supporting your upstream bioprocessing needs with efficiency and precision.

Key capabilities

  • Standard batch and fed-batch processes
  • Customized processes
  • 6 × 1 L glass fermentors
  • 1 × 15 L steel fermentor
  • 4 × 50 L dedicated steel fermentors for manufacturing
  • Periplasmic and cytoplasmic extraction
  • Inclusion body preparation

Key capabilities

  • Standard batch and fed-batch processes
  • Customized processes
  • 6 × 1 L glass fermentors
  • 1 × 15 L steel fermentor
  • 4 × 50 L dedicated steel fermentors for manufacturing
  • Periplasmic and cytoplasmic extraction
  • Inclusion body preparation

From Development to Manufacturing

Our upstream development workflows are designed with scalability in mind. Where relevant, we can support the transition from process development to in-house manufacturing of GMP-grade proteins under appropriate excipient guidelines and quality frameworks.

Read more about our work with GMP-grade proteins

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 

ryan polito expression services and stran development

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