Drug Candidate Development & Formulation
We use our extensive experience in recombinant protein expression to advance our services in the protein manufacturing field. Our dedicated team focuses on new technologies and innovative processes to optimize and streamline protein expression systems to accelerate production timelines and to increase yields.
We strengthen our pre-formulation and product development services continuously by integrating new cutting-edge technologies into our analytical development to be able to provide high quality and in-depth insights into new formulations.
Recombinant Protein Expression
Bioneer has for decades developed and produced recombinant proteins using both mammalian and microbial hosts.
We are continuously expanding and refining our mammalian and microbial protein manufacturing technologies and processes (both upstream and downstream).
In our current R&D program, we refine our solutions within both mammalian and microbial protein production.
Mammalian Cell Line Development:
Our cell line development team of dedicated scientists is implementing state-of-the-art innovative methods to enhance protein manufacturing. We focus on advancing techniques that improve yield, purity, and efficiency, driving progress in therapeutic proteins, including new protein modalities, like bispecific antibodies and protein-drug-conjugates (PDCs)
Our focus is to develop new targeted strategies through genetic engineering to speed up development of stable, high yield CHO cell lines. Additionally, we develop our facilities and capabilities for high through-put cell line selection and early process development enabling further scale-up development in our bioreactor platforms.
Microbial Fermentation:
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 fed to the bioreactor during the fermentation. To improve efficiency and yield, we are therefore establishing and developing standardized fed-batch fermentation processes that can be used for production of recombinant proteins in E. coli
This R&D program will significantly strengthen our capabilities in the protein manufacturing field in general and will be instrumental for our ambition of being a preferred R&D partner for companies developing and commercializing ancillary proteins and biologics.
In our current R&D program, we refine our solutions within both mammalian and microbial protein production.
Mammalian Cell Line Development:
Our cell line development team of dedicated scientists is implementing state-of-the-art innovative methods to enhance protein manufacturing. We focus on advancing techniques that improve yield, purity, and efficiency, driving progress in therapeutic proteins, including new protein modalities, like bispecific antibodies and protein-drug-conjugates (PDCs)
Our focus is to develop new targeted strategies through genetic engineering to speed up development of stable, high yield CHO cell lines. Additionally, we develop our facilities and capabilities for high through-put cell line selection and early process development enabling further scale-up development in our bioreactor platforms.
Microbial Fermentation:
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 fed to the bioreactor during the fermentation. To improve efficiency and yield, we are therefore establishing and developing standardized fed-batch fermentation processes that can be used for production of recombinant proteins in E. coli
This R&D program will significantly strengthen our capabilities in the protein manufacturing field in general and will be instrumental for our ambition of being a preferred R&D partner for companies developing and commercializing ancillary proteins and biologics.
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.
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.
Formulation Development
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 allow 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.
We also develop state-of-the-art laboratory models to support drug formulation characterization and development. These models will be based on clinical data that consider changes in the GI tract for selected diseases or conditions. This includes intestinal diseases and conditions leading to an elevated pH level in the stomach, which can be observed in different patient groups, especially among geriatric patients.
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.
Bioneer has vast experience in developing formulation technologies and principles for small molecules, peptides, and proteins including biologics.
We continue to look into new peptide formulation principles that allow 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.
We also develop state-of-the-art laboratory models to support drug formulation characterization and development. These models will be based on clinical data that consider changes in the GI tract for selected diseases or conditions. This includes intestinal diseases and conditions leading to an elevated pH level in the stomach, which can be observed in different patient groups, especially among geriatric patients.
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.
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