Sön 3 dec / År 41 / Nr 4 2023

Bioneer helps life science with R&D  

The Contract Research Organisation Bioneer acts as an external R&D department for the life science ecosystem of companies involved in therapeutic development. The company is seeing substantial growth partly driven by its impressive journey as a specialty-CRO for recombinant protein solutions.

The headquarter of Bioneer in Hørsholm, Denmark

The specialty-CRO Bioneer has consolidated its role as R&D partner to the life science industry.

At the core of its activities, Bioneer translates science and know-how into technology platforms and processes that enable the industry to speed up discovery and development of new therapeutics.

”In essence, we help companies with two things: To create the necessary data to establish proof of concept for their compounds, and to produce recombinant proteins,” says Bioneer’s Chief Scientific Officer, Christian Clausen.

Bioneer in reality serves as an extended R&D department for its partners. The company makes its know-how, advanced disease models, technology platforms and laboratory facilities available to help produce, characterize and select the best drug candidates and the best formulations in the important R&D phases where multiple concepts are still being tried out.

”We are particularly proud of the role we play to Scandinavian biotech and pharmaceutical companies. We have worked alongside many of the biotech teams from they were first established, which is really optimal and gives us the ability to exchange ideas with their scientific experts and be part of the strategic choices they make,” says Christian Clausen.

The CSO explains that, although Bioneer has been the ‘go-to’ partner for all matters related to production of biologics and specialty proteins for more than three decades, the journey still continues.

”We have worked with so many challenging proteins over the years, most of which have been produced using our microbial platforms. Now we have expanded our capabilities and our laboratories to also handle production of more mainstream biologics using mammalian platforms,” says Christian Clausen.

From feasibility to formulation

Bioneer develops and produce specialty proteins and biologics for early discovery studies and design the early CMC (chemistry, manufacturing, control) processes for later transfer to Contract Manufacturing Organizations (CMOs) if needed.  The company can help companies from ‘feasibility to formulation’ as they put it.

The path from early feasibility expression of a specific protein to CMO transfer is a step-wise process involving cell line development, upstream production (fermentation, cultivation) in either mammalian or microbial systems, downstream purification, protein characterization, formulation and stability analysis.

Bioneer has successfully assisted companies from the first feasibility studies and all the way to the transfer of GMP compliant protocols to CMOs worldwide making the scale-up production for clinical trials possible for the companies.

This require appropriate and advanced facilities as well as a highly skilled team of experts with experience in both cell culture and protein chemistry. Bioneer has recently finalized the construction of new facilities for both cell culture and protein purification, where the team now will be able to strengthen and expand their services to the benefit of the increasing number of companies developing new biologics and associated specialty proteins.    

Life Science solutions of tomorrow

Bioneer has a clear strategy to continue its investments into capabilities and technologies to serve the growing biologics field.

The company has recently initiated a 4-year R&D program focusing on new technology developments that can help further improve productivity in the production phase and ensure that protein functionality is optimized during purification.      

“We are excited to see how far this program will take Bioneer, but the ambitions are high and we expect that the results of the program will make Bioneer capable of matching the future demands for improved productivity and quality in the field for biologics,” says Christian Clausen.   

For companies collaborating with Bioneer, they encounter a dedicated discovery and development partner; skilled scientists and access to advanced technology platforms and state-of-the-art wet lab facilities.

Bioneer’s CSO emphasizes that key to the company’s success and ability to provide better Life Science solutions of tomorrow is their role as a trusted strategic R&D partner. Not only to the biotech and pharmaceutical companies but also to the surrounding industry of CMOs, large reagent suppliers and independent consultants.