Advancing Affordable Biologics
About Ardent Biopharma
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 generation of biosimilar development and manufacturing. 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 at just 10–20% 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.
In addition to developing biosimilars, Ardent will license its proprietary CM technology platform to non-competing partners, enabling broader access to next-generation manufacturing.
Team
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 process engineering and regulatory affairs to CMC, GMP compliance, and quality assurance. Ardent’s team has consistently been at the forefront of innovation, pioneering solutions in continuous processing (e.g., continuous chromatography, VI-C/D, centrifugation, and end-to-end automation) long before these methods became industry standards. Several of these innovations are protected by patents with Ardent team members named as inventors.
Key Team Members
Collaborations
Ardent Biopharma collaborates closely with simAbs (a CDMO), forming a synergistic partnership with strong capabilities in mAb development and continuous manufacturing. This alliance is strategically positioned to significantly reduce cost of goods (CoGs), a crucial step toward increasing biologic accessibility in developing regions.
We actively seek partnerships that share our mission of reducing the cost of mAbs and non-mAb proteins. Monoclonal antibodies remain the largest and fastest-growing segment of the biologics market, currently accounting for 60% of global biologics production.
Technology Licensing
Ardent is developing a next-generation CM platform for the production of mAbs and other therapeutic proteins. This system features fewer process steps and a novel automation framework incorporating advanced Process Analytical Technology (PAT) and digital recordkeeping.
Utilizing commercially available unit operations—now matured through developments by key suppliers—our platform ensures reliable and compliant continuous processing at virtually any scale.
Ardent offers:
Full CM platform licensing
Implementation services
On-site training for your development teams
Equipment specification and procurement
Field-lab-based process train setup (50–2000L scale)
Process transfer and operational commissioning at your facility
Template validation documentation and batch records
Optional software updates and c analytics (fixed annual fee)
Implementation timelines range from 12–15 months, depending on project scale and equipment lead times. We aim to be your trusted partner in CM deployment.
Biosimilar Products
Ardent is developing a pipeline of biosimilars using its advanced CM platform. With the anticipated elimination of Clinical Efficacy Studies (CES) 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. Upon market validation, production will transition to Ardent’s dedicated CM facility in the Netherlands.
Ardent’s first 2 biosimilar antibodies are targeting cancer and autoimmune diseases.
Market Authorizations are targeted for 2030 and 2031, respectively. Future expansion will focus on building a robust and diversified biosimilar portfolio.
Careers
Software Engineers & Data Scientists
For CM system integration, AI/ML advancements, and optimization
Analytical Development Experts
For analytical design, contract lab management, similarity, stability studies, and PAT
Process Development Engineers
Focused on CM implementation, process characterization, and continuous improvement
Interested candidates can contact us at: info@argentbiopharma.com
Contact
Ardent Biopharma B.V.
Koninginneweg 85
2012 GL Haarlem
The Netherlands
Email: info@ardentbiopharma.com
Visit address
J.H. Oortweg 21
2333 CH Leiden
The Netherlands