Author Archives: Bala Raghunath

Integrity Testing of Ultrafiltration Systems for Biopharmaceutical Applications

    Ultrafiltration (UF) is a membrane-based separation technology commonly used in the biopharmaceutical industry for concentration or diafiltration of protein solutions to remove low–molecular-weight (LMW) impurities or exchange buffers. The nominal MW limit of UF membranes ranges from 1,000 Da (1 kDa) to 1,000,000 Da (1,000 kDa). A target product is retained by the membrane while lower-MW solutes or impurities pass through (1). For a target product with a smaller MW than the impurities, separation is accomplished by allowing…

Sterilizing-Grade Filter Sizing Based on Permeability

    Sterilizing filtration renders biotherapeutics free of biocontamination. In many cases, sterilizing-grade filters also reduce bioburden or facilitate closed or aseptic processing. They are used to filter active pharmaceutical ingredients (APIs), formulated bulk, cell culture media, buffer, additives, process intermediates, and so on. Such applications are often critical for ensuring a successful batch operations. Nonetheless, a significant amount of time and resources are typically not devoted to establishing filter sizing requirements for “simple” applications such as buffer filtration. Here,…