Under the agreement, the partners will implement a state-of-the-art continuous manufacturing platform, beginning at laboratory scale and progressing to 50 L GMP scale. Both biosimilars will be developed from highly productive perfusion cell lines, with cost-of-goods optimization as a central design principle throughout process development and GMP manufacturing.

As the Contract Development and Manufacturing Organization (CDMO), simAbs will be responsible for all drug substance–related activities. These include cell line development, analytical development, process development, master cell bank manufacturing, biosimilarity testing, stability studies, scale-up, clinical trial material manufacturing, process characterization, and process performance qualification (PPQ) runs.

Ardent Biopharma, as the biosimilar product owner, will lead drug product development, pharmacokinetic and safety clinical trials, and all regulatory submissions. Following development, Ardent Biopharma will assume responsibility for commercial manufacturing at its proprietary manufacturing facility, operating at 500 L and 1,000 L scales.

In addition, simAbs and Ardent Biopharma will collaborate on the development of a next-generation continuous manufacturing process incorporating digital twin technology supported by artificial intelligence and machine learning. The shared ambition of this program is to achieve unprecedented reductions in cost of goods through highly automated, lights-off GMP manufacturing, setting a new benchmark for biosimilar production efficiency.

“This collaboration underscores the DNA of both companies with respect to the future of continuous manufacturing” said Ard Tijsterman, CEO of Ardent Biopharma. Our key goal to make biosimilars at very low costs for affordability and accessibility for all patients takes a next step with this partnership.

“We are honoured to enter this strategic European partnership. This collaboration fills us with pride as we shape the future of biopharmaceutical development and GMP manufacturing together. With the expertise of both teams, we are confident that we will be a driving development engine for biosimilars—one that will deliver meaningful benefits for the patients we serve” said Koen Dierckx, CEO of simAbs.

About simAbs

simAbs NV is a Belgian Contract Development and Manufacturing Organization specializing in continuous biologics manufacturing. The company leverages a proprietary end-to-end platform encompassing cell line development, process and analytical development, and GMP manufacturing.

About Ardent Biopharma

Ardent Biopharma BV is a Dutch biosimilars company with the ambition to become a leading low-cost provider of monoclonal antibody biosimilars. The company plans to seek regulatory approval for its biosimilars with only pharmacokinetic safety studies and to commercialize its products through highly experienced marketing and sales partners.