Is magnetic separation a good alternative bioseparation technique to packed-bed chromatography in downstream processing of biologics? Researchers from the Technical University of Munich discuss the pros and cons.
The growing demand for biopharmaceuticals, including monoclonal antibodies (mAbs), therapeutic enzymes, and gene therapies, presents challenges for conventional downstream processing (DSP). Traditional packed-bed chromatography, a widely used technique, faces limitations such as slow mass transfer, high processing costs, and inefficiencies in handling complex biologics. As an alternative, magnetic separation has emerged as a promising technique for process intensification, offering faster processing times, higher adaptability, and potential cost savings.
Reduction of costs and time-consuming opertaions
Magnetic separation leverages functionalized magnetic particles (MPs) that bind to target molecules and can be retained using magnetic fields for buffer exchange. Unlike chromatography, MPs operate in suspension, eliminating flow restrictions and enhancing mass transfer efficiency. This technique enables integration of clarification, filtration, and capture steps, reducing the need for costly and time-consuming unit operations.
Effective
For mAb purification, magnetic separation can address challenges posed by high cell density cultures and large-volume perfusion processes. Studies have demonstrated its effectiveness, with higher process productivity compared to chromatography. However, current limitations include low concentration factors and the lack of large-scale magnetic separation systems. Advancements in separator design and semi-continuous processing could significantly enhance scalability.
Beyond mAbs, magnetic separation holds potential for purifying novel modalities such as viral vectors, mRNA, and CAR-T cells. Early research has shown promising results, but large-scale applications remain underdeveloped. Additionally, for recombinant protein purification, magnetic separation can provide cost-effective solutions using non-functionalized MPs, though further improvements in large-scale equipment are needed.
Enhancing productivity
Looking ahead, magnetic separation requires further technological advancements, including improved particle capacity, automation, and real-time process control. Its main advantages—fast target binding, seamless process integration, and cost-efficient scalability—make it a strong candidate for transforming DSP in biopharmaceutical manufacturing. However, acceptance within the strictly regulated industry remains a challenge. With continued research and development, magnetic separation has the potential to enhance productivity, sustainability, and efficiency in bioseparation processes.
Bron: www.bioprocessonline.com