Drug Candidate Development & Formulation

Bioneer’s research strategy addresses novel solutions for drug discovery and development that fulfil future needs of companies, research institutes, and Health Care.

Recombinant Protein Expression

Bioneer has for decades developed and produced recombinant proteins using both mammalian and microbial hosts.

We develop and refine protein manufacturing technologies including downstream and upstream technologies.

In our current R&D program, we refine our solutions within both mammalian and microbial protein production.

Mammalian protein expression:

We develop new targeted strategies through genetic engineering to speed up development of stable mammalian cell lines, primary CHO cells and develop our facilities further to be able to scale up our production capacity.

Microbial protein expression:

Fermentation processes are typically either batch or fed-batch. The batch process is easier to operate but also results in lower biomass yield

and longer down time compared to a fed-batch process where nutrients are feed to the bioreactor during the fermentation. The fed-batch regime is typically used for manufacturing of biologics by CMO’s. Being able to optimize fermentation processes will have a huge impact on the ability to produce biologics in high yields for the benefit of our clients. We therefore establish and develop standardised fed-batch fermentation processes that can be used for production of recombinant proteins in E. coli, which later can be transferred to a CMO for cGMP manufacturing with the aim of providing a new biologic for the clinic and the market.

This R&D program will significantly increase our capabilities in the protein production field and will be instrumental for our ambition of being a preferred R&D partner for companies working with biologics.

We have a strong expertise in immune-oncology and can assist companies with a broad range of in vitro models and assays. These includes:

  • Immune suppressor assays including T-regs
  • Dendritic / T-cell model including immune suppressive DCs, so-called DC10s
  • Simulated tumor microenvironment by using Tumor-conditioned Media (TCM)
  • Different immortalized cancer cell models
  • Different cell co-cultures mimicking cancer micro environments
  • Detection of tumor cells in blood
  • Checkpoint inhibitor blockade
  • Reprogramming and genome editing of immune cells
  • Cytokine release assays
  • Generation of cancer-specific cell lines
  • Advanced biomarker analysis from single cells to complex tissue samples.

Above is a selection of model and assays in the immuno-oncology field that we can perform. Depending on individual project and client needs, we will tailor and adapt the study set-up to fit the specific purpose.

For further information, please contact Department Head Bjørn Holst by phone +45 45160444 or email.

Protein Refolding

Bioneer has extensive experience in most aspects of protein science and key determinants affecting protein folding.

Many proteins fail to fold into their native state when expressed in E. coli and it is necessary to refold the proteins to ensure their functionality.

We develop strategies and protocols that increase the speed and success rates of protein refolding processes. We do that by optimizing key parameters and identify commonalities depending on the characteristic of each protein.

Bioneer has extensive experience in most aspects of protein science and key determinants affecting protein folding.

We develop strategies and protocols that increase the speed and success rates of protein refolding processes. We do that by optimizing key parameters and identify commonalities depending on the characteristic of each protein.

Targeted Formulation

Bioneer has vast experience in developing formulation technologies and principles for both small molecules and biologics, including peptides and proteins.

We continue to look into new peptide formulation principles that allows for a more targeted delivery approach. This includes oral delivery technologies based on peptide-lipid complexes in combination with self-emulsifying formulations. Additionally, we continue to strengthen our solutions in the area of poorly soluble compounds where we work with

different aspects of amorphous solid dispersions.

Our ambition with this program, is to develop formulation technologies to support the continuously increasing requirements for formulation of poorly-soluble drug compounds and emerging biological therapeutics.

We continue to look into new peptide formulation principles that allows for a more targeted delivery approach. This includes oral delivery technologies based on peptide-lipid complexes in combination with self-emulsifying formulations. Additionally, we continue to strengthen our solutions in the area of poorly soluble compounds where we work with

different aspects of amorphous solid dispersions.

Our ambition with this program, is to develop formulation technologies to support the continuously increasing requirements for formulation of poorly-soluble drug compounds and emerging biological therapeutics.

For further information
please contact:

Christian Clausen
CSO