Biopharmaceuticals purification by continuous membrane-assisted crystallization achieving lower cost and intensified processes

Introduction

With the growing global demand for biological medicines to address new therapeutic areas, the BIOPURE project will deliver a step change in monoclonal antibodies (mAbs) purification through the implementation of radically new and disruptive technology to recover mAbs-products in the solid-state directly from cell-free culture fluids.

Benefits of BIOPURE

BIOPURE promises to:

• Lower manufacturing and purchase of equipment costs with a smaller footprint.
• Simplify logistic chains.
• Enhance environmental sustainability by avoiding extensive use of chemicals, compared to the standard chromatography-based platforms.

This project opens the doors to new possibilities and biomedicines that have been too challenging economically or technologically. As a result, citizens will have access to a more affordable and diverse selection of new generation biomedicines.

Technological Development

The proposed membrane-based technology has already been proved at the laboratory scale (TRL4) as a cheaper and easily scalable alternative to protein A chromatography for mAb purification.

Next Steps

The next step is to:

1. Demonstrate the generalized efficiency of the technology.
2. Scale it up to TRL6 through the design of a fully automatized prototype that will be operated continuously.
3. Ensure compliance with quality and regulations for biopharmaceutical productions.

Market Validation

In addition to technological development, the new BIOPURE technology will be validated with real market players. This will lead to:

• Verifying the planned business model.
• Developing the IPR management plan.
• Establishing the associated financial planning included in the go-to-market strategy.

Conclusion

By achieving the main objectives of BIOPURE, it is expected that the adoption of the membrane-assisted method for mAb-products purification will provide a breakthrough advancement in terms of productivity efficiency via continuous manufacturing, and cost reduction via process intensification.