If you are a mAb manufacturer dealing with the high cost of protein-A resins and heavy chemical use — this project developed a membrane-assisted crystallization (MAC) system that recovers products in solid state. This reduces equipment costs and shrinks the production footprint.
Low-Cost Continuous Purification System for Monoclonal Antibody Production
Imagine trying to pick out specific gold beads from a bucket of sand using an expensive, slow filter that needs constant cleaning. This technology replaces that expensive filter with a smart membrane that turns the medicine into a solid powder directly. It's like switching from a slow, chemical-heavy wash to a fast, clean-drying process.
What needed solving
Current monoclonal antibody purification relies on expensive protein-A resins and heavy chemical use. This creates high manufacturing costs and an unsustainable environmental footprint, limiting patient access to affordable therapies.
What was built
A fully automatized prototype for membrane-assisted crystallization (MAC) that recovers mAbs in solid-state continuously.
Who needs this
Who can put this to work
If you are a biosimilar developer dealing with expensive downstream processing that makes drugs unaffordable — this project developed a continuous purification method that lowers manufacturing costs. This allows for a more diverse selection of affordable biomedicines.
If you are a CDMO dealing with unsustainable environmental impacts from chromatographic columns — this project developed a disruptive MAC technology that avoids extensive chemical use. It simplifies the logistic chain and increases productivity efficiency.
Quick answers
How does this technology reduce production costs?
It replaces expensive protein-A based resins and reduces the large amount of chemicals needed for column regeneration. Based on project data, it lowers both manufacturing and equipment purchase costs.
Is this technology ready for industrial-scale use?
The project aims to scale the technology from TRL4 to TRL6. This involves designing a fully automatized prototype capable of continuous operation and regulatory compliance.
What is the plan for IP and licensing?
The project includes the verification of a planned business model and an IPR management plan as part of its go-to-market strategy.
Does this process meet pharmaceutical regulations?
A primary objective is to develop a prototype capable of compliance with quality and regulations for biopharmaceutical productions.
How does this integrate into existing workflows?
It is designed to replace the protein A chromatographic step in the downstream processing (DSP) sequence, recovering antibodies directly from clarified cell culture fluids.
Who built it
The consortium is well-balanced for commercialization, consisting of 6 partners across 4 countries. With a 50% industry ratio (3 industrial partners, including 3 SMEs), the project ensures a strong link between research (2 partners) and market application, focusing on a viable go-to-market strategy.
Contact the Consiglio Nazionale delle Ricerche (CNR) in Italy.
Talk to the team behind this work.
Contact us to connect with the BIOPURE consortium for licensing opportunities.