Downstream Process Intensification (PI): The Impact of Inline Buffer Exchange SSTFF, RTF Chromatography, and Tankless TFF

New Paradigm in Downstream Purification

The advancements in biopharmaceutical production have led to the development of innovative methods for downstream purification. Recent breakthroughs involve the integration of inline buffer exchange using SSTFF (steady-state tangential flow filtration), Recirculating Tangential Flow (RTF) chromatography, and TMP/CF independent tankless TFF (tangential flow filtration) processes. These technologies enable the handling of particulates and cells in an inline fashion, direct loading of unconditioned feed to chromatography, and immediate connection of TFF after chromatography, signifying a monumental shift in the way protein purification, particularly monoclonal antibody (mAb) purification, can be performed.

Streamlining the Purification Process

Traditionally, a typical mAb downstream purification process could entail up to nine distinct steps. This not only requires substantially more time but also utilizes a larger footprint for equipment and facility space. However, by employing the groundbreaking techniques of inline buffer exchange, RTF chromatography for particle/cell handling, and tankless TFF, this complex nine-step process can be condensed into just two to three connected batches. Such a transformation is significant as it directly addresses some of the long-standing challenges in the industry, including cGMP space limitation, lengthy process cycle time, and efficiency.

The Advantages of Reduced Processing Time and Footprint

Reducing the total batch cycle time has profound implications. First and foremost, shorter cycle times can lead to greater productivity in biopharmaceutical manufacturing. Faster processing allows for a quicker turnaround, enabling companies to meet rising global demands for mAbs and other protein drugs without compromising on quality. Additionally, a condensed process reduces the operational costs associated with both manpower and resource utilization.

Moreover, with a smaller equipment footprint, manufacturers can optimize their facility layout, freeing up valuable space that can be repurposed for other critical operations or expansions. This efficient use of space is not just a matter of convenience; it can significantly lower capital expenditures and enhance overall operational cost/efficiency.

The Future of Protein and mAb Purification

The shift to inline buffer exchange and tankless TFF is a game changer for the pharmaceutical industry. By simplifying the mAb downstream purification process into fewer steps, companies can improve efficiency, reduce costs, and maximize their production capabilities. As technology continues to evolve, the focus will undoubtedly remain on enhancing these methods further, paving the way for even more advancements in bioprocessing. The combination of these novel approaches marks a significant leap toward optimizing protein therapeutics such as mAb production, making it more sustainable and more capable of meeting global healthcare needs.