Recent advancements in Continuous Manufacturing (CM), artificial intelligence and machine learning (AI/ML) and anticipated regulatory shifts—such as the potential waiver of Phase III clinical trials—have paved the way for a new biosimilar development and manufacturing company. Ardent Biopharma is seizing this opportunity to redefine cost efficiency in the production of monoclonal antibodies (mAbs) and other therapeutic proteins.

Leveraging these innovations, we aim to deliver biosimilars below 20% of the originator price, significantly improving global affordability and accessibility to life-saving or life-enhancing biologic therapies. Ardent aspires to become a cost leader in the biosimilars industry. Both first and second wave biosimilars will be developed. 

Development will be done in close collaboration with our partners until we can operate from a proprietary facility in The Netherlands. Future product M&S will be realized through specialized parties per region.

Ardent Biopharma’s core team brings together over 100 years of combined experience in biologics development and manufacturing, with deep expertise in Continuous Manufacturing (CM) of monoclonal antibodies.

Our multidisciplinary team covers the full spectrum of product development—from cell line development, process & analytical development, CMC, GMP manufacturing & compliance, quality assurance, clinical and regulatory affairs.

Ardent’s team has consistently been at the forefront of innovation, pioneering solutions in continuous processing long before these methods became industry standards. Several of these innovations are protected by patents with Ardent team members named as inventors.

Ardent is developing a pipeline of biosimilars. With the anticipated elimination of Clinical Efficacy Studies (Phase 3) for many biosimilars, development costs are expected to decline dramatically—making manufacturing efficiency the key driver of cost reduction.

Initial development and early-stage manufacturing will be outsourced to trusted CDMOs and contract labs. Upon market validation, production will transition to Ardent’s dedicated CM facility in the Netherlands.

Ardent’s first 2 biosimilar antibodies are targeting cancer (AB01) and autoimmune diseases (AB02).

The first Market Authorizations are planned for 2030 and 2031, respectively. Future expansion will focus on building a robust and diversified biosimilar portfolio.

Ardent Biopharma collaborates closely with simAbs (Belgian CDMO), forming a synergistic partnership with strong capabilities in mAb development and continuous manufacturing. This alliance is strategically positioned to develop low COGs biosimilars with long term stability and robust structural & functional comparability data. 

We actively seek partnerships that share our mission of reducing the costs of mAb manufacturing and development timelines. Manufacturing excellence will be realized via our continuous improvement program. Use of digital twins combined with real-life data will result in 24/7 lights-off operation, electronic recording and partial parametric release.