INDUSTRIES
Hybrid R&D Approach
Accelerate your cell therapy to the patient
Your Advanced Therapy Partner
Welcome to Antleron: Pioneering the Future of Biopharmaceutical Manufacturing
Biopharmaceutical manufacturing has evolved from large-scale, manual operations to automated systems and on to personalized micro-production. At Antleron, we lead the way with a novel Hybrid R&D Approach, a living, fully digitalized ecosystem where cells themselves become the factory, producing personalized medicines in a closed, automated, and intelligently monitored environment.
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We specialize in advanced therapy medicinal product and process modeling, wet lab R&D, and clinical & industrial translation. By combining small-scale, custom bioreactors with digital twins, our proprietary smart bioprocess platform accelerates bioprocess development and seamlessly translates it into clinical and industrial manufacturing systems.
The innovative Antleron platform tackles the key challenges of personalized cell and gene therapy, from process development to quality assurance and scalability, faster, more efficiently, and cost-effectively. The result: better, safer, and more sustainable therapies that are created in an environment that is GMP-ready.
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With our extensive expertise, team, technologies, tools, facilities, and equipment, we design, simulate, build, and test bespoke cell-based bioprocesses in the lab, then translate them into fully manufacturable cell and gene therapy solutions according to your production needs.
Smart Scaled-Down Models
From discovery to process development, Antleron’s smart scale-down model service combines custom, lab-scale, modular bioreactors with its digital enhanced twin platform Nexus, to predict, develop and optimize from bench to clinical-scale bioprocesses and manufacturing systems. Antleron’s bioprocess development platform CellGuide® completes its smart scale-down model offering by enabling improved quality, consistency and scalability from lab to patient for bespoke therapies.
Targeted Process Dev
At Antleron, we help you create a detailed Target Product Profile and define measurable Critical Quality Attributes that capture the essence of your desired product.
We identify the critical process parameters, product parameters, and risks that could influence product quality. Using our Quality by Design methodology, Antleron systematically maps these factors, integrates mitigation strategies, and embeds smart monitoring tools into your development process.
This approach allows you to rapidly establish normal operating ranges where your product consistently meets the defined quality attributes, ensuring robust, reliable, and reproducible outcomes from day one.
The Right Scale
"First time right" is essential for your projects. At Antleron, we design and implement a smart scaling strategy that ensures your process evolves seamlessly from lab concept to clinical and industrial production.
We integrate scalability at the start of our process development, so every design choice supports efficient technology transfer, robust performance, and consistent product quality. By combining model-based design, experimental validation, and digital twins, Antleron enables faster optimization and de-risks the transition between development phases.
With a first-time-right mindset, you save valuable time and resources, achieving reliable, scalable, and compliant production pathways tailored to your product.
Antleron Services
Antleron offers tailored services to support MSC therapy developers at every stage:
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Custom Process Development: From donor screening to scale-up, we co-develop optimized MSC expansion protocols.
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CRO Support: Feasibility studies, assay development, and potency testing tailored to your therapeutic goals.
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Regulatory-Ready Workflows: Support for CQA definition, comparability studies, and documentation aligned with EMA/FDA expectations.
