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The Shift to High Concentration mAbs: 3 Critical UF/DF Challenges and How to Solve Them
As monoclonal antibody therapies continue to evolve, the industry is rapidly shifting from traditional mAb formulations to high concentration mAbs to enable subcutaneous delivery, improve patient convenience, and support next generation therapeutics. While this shift delivers clear clinical benefits, it also introduces new risks and complexities particularly during ultrafiltration and diafiltration (UF/DF). In this webinar, we’ll examine how increasing protein concentration fundamentally changes UF/DF behavior—and why legacy approaches often struggle as viscosity rises and operating windows narrow. We’ll break down the three most critical UF/DF challenges associated with high concentration mAbs and discuss practical strategies to address them using modern TFF platforms. Key topics include: Why the industry is shifting toward high concentration mAbs—and what this means for downstream bioprocessing The three critical UF/DF challenges at high concentration: Managing viscosity and its impact on flux, pressure, and process control Preventing fouling and polarization that limit performance and scalability Reducing aggregation risk during concentration and diafiltration How modern, automated TFF system design can help mitigate these risks What to consider when adapting UF/DF strategies for development, scale up, and manufacturing Whether you are developing next generation mAbs or scaling existing programs to higher concentrations, this session will provide practical insights to help you build more robust, repeatable UF/DF processes for the high concentration era.
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Four Common Pitfalls to Avoid in UF/DF Setup and Scale-Up
Ultrafiltration Diafiltration (UF/DF) processes that look robust at the development scale often expose critical weaknesses during scale-up or tech transfer—resulting in capacity constraints, excessive manual intervention, delayed timelines, or manufacturing risk. In many cases, these issues trace back to early UF/DF decisions that seemed reasonable at the time but didn’t fully account for scalability, system design, or cross-functional alignment. In this webinar, we’ll break down four of the most common—and costly—pitfalls in UF/DF setup and scale-up, including poor filter sizing and membrane selection, overreliance on manual operations, system design limitations, and breakdowns in communication between Process Development and MSAT teams. Through practical examples drawn from downstream workflows, we’ll show how these pitfalls emerge, why they persist, and how they impact process robustness and manufacturing success. Viewers will leave with practical strategies to design more scalable UF/DF processes, reduce manual burden, improve system selection, and strengthen PD–MSAT collaboration—helping teams avoid late-stage surprises and enabling smoother tech transfer to manufacturing. Avoid scale-up surprises with membrane selection strategies that are fit-for-purpose Reduce manual burden and operational risk by understanding when automation and system design choices matter most for robust, scalable UF/DF operations Enable smoother tech transfer by improving alignment and communication between Process Development and MSAT teams early in process design