Hasselt, Belgium & Leiden, The Netherlands – April 7th, 2026
We are proud to highlight a new strategic collaboration between our member, simAbs, and Ardent Biopharma. Together, they are taking an important step towards the future of biosimilar manufacturing.
The partnership focuses on the development of monoclonal antibody biosimilars using continuous manufacturing technologies at industrial GMP scale. By combining their expertise, both companies aim to increase efficiency, reduce costs and improve patient access to biologics worldwide. The program will start at lab scale and evolve towards 50 L GMP manufacturing, with a strong focus on highly productive perfusion cell lines and cost-of-goods optimisation from early development onwards.
As CDMO partner, simAbs will lead all drug substance activities, including:
- Cell line development
- Analytical and process development
- Master cell banking
- Biosimilarity and stability studies
- Scale-up and clinical trial material manufacturing
- Process characterisation and PPQ
In parallel, both partners will collaborate on the development of a next-generation continuous manufacturing platform, integrating digital twin technology, artificial intelligence (AI) and machine learning.
The shared ambition is to enable highly automated “lights-off” GMP manufacturing and to set a new benchmark for efficiency in biosimilar production.
As Ard Tijsterman (CEO of Ardent Biopharma) highlights, this collaboration marks an important step towards making biosimilars more affordable and accessible for patients worldwide.
Koen Dierckx (CEO of simAbs) adds that the partnership brings together complementary expertise to help shape the future of biopharmaceutical development and GMP manufacturing in Europe.
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.
Read the complete press release here: https://lnkd.in/dSY3ZWAF
