Upstream and downstream bioprocessing rely on various forms of filtration. Some of the most widely used methods include a tangential flow filter (TFF). Instead of flowing through a filter, a sample flows over a TFF. According to Luke McCarney, a downstream R&D engineer at Cytiva, and his colleagues, TFF is “used in nearly all bioprocesses for concentration and buffer exchange.” These scientists developed a four-step approach to select the best TFF format for a specific therapy.
A bioprocessor can choose from various TFF formats, but hollow fiber modules (HF) or flat-sheet cassettes (FS) are usually selected for large molecules. In many cases, HF and FS are both used in different stages of producing one biotherapeutic, such as a monoclonal antibody. Still, “the industry has not converged on an optimal TFF format for processing” for some therapies, such as ones based on cells or viral vectors, stated McCarney and his colleagues.
That’s why McCarney’s team saw the need for a systematic approach to picking a TFF format. In their method, the steps are: system limitations, such as the pump and filter; process and membrane conditions, which include the crossflow rate, loading, and more; performance, such as yield and the removal of impurities; and non-performance, which includes cost, scale, and so on.
Using strains of human embryonic kidney cells, HEK-293H and HEK-293T cells, McCarney’s group produced two types of adeno-associated viruses, AAV5 and AAV8, respectively. In the processing of these AAVs, the scientists used their four-step approach to evaluate HF and FS methods of TFF. The type of TFF method impacted some aspects of the AVV production, but not others, which highlights the reason to make comparisons across a collection of factors for the production of any biotherapeutic.
That list of factors, McCarney’s team noted, goes beyond those featured in their four-step process. As these scientists emphasized, this process “gives a broad roadmap for hollow fiber and flat sheet comparison” when optimizing the bioprocessing of a specific therapeutic.
That optimization, though, usually depends on various objectives. As McCarney and his colleagues put it: “Although performance is often seen as a key driver for process design, there are many other factors that can be equally as important to consider.”
The post Four-step Approach to Select Best TFF for Specific Therapy appeared first on GEN - Genetic Engineering and Biotechnology News.
A bioprocessor can choose from various TFF formats, but hollow fiber modules (HF) or flat-sheet cassettes (FS) are usually selected for large molecules. In many cases, HF and FS are both used in different stages of producing one biotherapeutic, such as a monoclonal antibody. Still, “the industry has not converged on an optimal TFF format for processing” for some therapies, such as ones based on cells or viral vectors, stated McCarney and his colleagues.
That’s why McCarney’s team saw the need for a systematic approach to picking a TFF format. In their method, the steps are: system limitations, such as the pump and filter; process and membrane conditions, which include the crossflow rate, loading, and more; performance, such as yield and the removal of impurities; and non-performance, which includes cost, scale, and so on.
Using strains of human embryonic kidney cells, HEK-293H and HEK-293T cells, McCarney’s group produced two types of adeno-associated viruses, AAV5 and AAV8, respectively. In the processing of these AAVs, the scientists used their four-step approach to evaluate HF and FS methods of TFF. The type of TFF method impacted some aspects of the AVV production, but not others, which highlights the reason to make comparisons across a collection of factors for the production of any biotherapeutic.
That list of factors, McCarney’s team noted, goes beyond those featured in their four-step process. As these scientists emphasized, this process “gives a broad roadmap for hollow fiber and flat sheet comparison” when optimizing the bioprocessing of a specific therapeutic.
That optimization, though, usually depends on various objectives. As McCarney and his colleagues put it: “Although performance is often seen as a key driver for process design, there are many other factors that can be equally as important to consider.”
The post Four-step Approach to Select Best TFF for Specific Therapy appeared first on GEN - Genetic Engineering and Biotechnology News.