Advancing Affordable Biologics

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

Ard Tijsterman
Jaap den Engelsman
Maarten Pennings
Menne Zaalberg

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

Get in Touch

Ard Tijsterman - CEO

Ard has wide experience in project and organization consulting in the biopharmaceutical arena. He is an entrepreneur and business developer with his roots in biopharmaceutical production, EU/US compliance, validation, process development and drug development (RA, CMC, non-clinical & early stage clinical). Co-founder and co-owner of a number of companies: Xendo, Tarpon Biosystems and BiosanaPharma. As the CEO he has the overall responsibility for the company’s activities and strategy.

Jaap den Engelsman - CFO

Jaap den Engelsman is a highly experienced CFO with a track record at a diversity of internationally operating companies that are active in the food and biotechnology field. A number of these companies are: Cavitus, DSM Food Specialties and DSM Biologics. Jaap is co-founder of BiosanaPharma. In his role, Jaap provides continuous insight in and strategic advice on the financial options and position of the company.

Maarten Pennings - CTO

Maarten Pennings has over 25 years of experience in the development of biopharmaceuticals. He spent 12 years at Xendo (now ProPharma Group) as a consultant process development, worked in projects on antibiotics, plasma proteins, antibodies and viral vaccines. Over the past 10 years as CTO at BiosanaPharma, Maarten led the development of Biosana’s 3C GMP continuous manufacturing platform for an Omalizumab biosimilar to late-stage level.

Maarten has been working on the development of continuous manufacturing in biopharma since 1999 and is co-inventor of the BioSMB®. At Ardent Biopharma,  he leads process development and manufacturing, and CM technology development.

Menne Zaalberg - COO

Menne Zaalberg has 30 years of experience in the biotechnology and pharmaceutical industry which includes leading the team with experts and leading the operations of the Process Division within ProPharma Group. As a project manager Menne was responsible for many projects for internationally located companies. These projects include new and revamp biopharmaceutical GMP production suites including (continuous) disposable biomanufacturing trains, clean utilities and equipment. Menne is responsible for operations, HR and IT.