A platform for research: civil engineering, architecture and urbanism
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Membranes for virus removal by size exclusion ; Membranen zur Entfernung von Viren mittels Größenausschluss
Modern biopharmaceutical processes implement comprehensive virus clearance strategies to minimize the threat of viral contamination of drugs and ensure patient safety. Besides testing of source materials and the finally formulated drug, manufacturing processes based on mammalian cell lines are required by the regulatory agencies to include at least two dedicated orthogonal unit operations for the inactivation or removal of endogenous or adventitious viruses. Throughout the last three decades, size exclusion based virus filtration using porous membranes in dead-end mode has become an industry standard known for its reliability and robustness to clear viruses while not affecting product quality and allowing high product recovery. Virus filtration membranes (VFMs) have complex porous structures capable of retaining small viruses such as parvoviruses having 18-24 nm in diameter by at least 99.99 % corresponding to a log10 reduction value (LRV) >= 4. At the same time, typical product molecules like monomeric IgG-type monoclonal antibodies, having diameters of 9-12 nm, need to be transmitted by more than 95 %. Exhibiting pore sizes (nominally 20 nm) within the same magnitude of both product and contaminant species renders the separation task that VFMs fulfil intensely sophisticated. For comparison, other size-based unit operations utilizing membranes, such as microfiltration, separate species differing by at least one order of magnitude in hydrodynamic diameter. This high demand for selectivity renders the development and manufacturing of VFMs a challenging task. Besides the obligatory virus retention performance, the main application relevant performance characteristics of a VFM are the water/buffer permeability and the fouling robustness. From a material scientific perspective, these application characteristics are closely linked to the pore size distribution (PSD) in the separation-active layer (SAL), the pore size gradient (PSG) along the membrane thickness and the characteristics of the membrane surface. In ...
Membranes for virus removal by size exclusion ; Membranen zur Entfernung von Viren mittels Größenausschluss
Modern biopharmaceutical processes implement comprehensive virus clearance strategies to minimize the threat of viral contamination of drugs and ensure patient safety. Besides testing of source materials and the finally formulated drug, manufacturing processes based on mammalian cell lines are required by the regulatory agencies to include at least two dedicated orthogonal unit operations for the inactivation or removal of endogenous or adventitious viruses. Throughout the last three decades, size exclusion based virus filtration using porous membranes in dead-end mode has become an industry standard known for its reliability and robustness to clear viruses while not affecting product quality and allowing high product recovery. Virus filtration membranes (VFMs) have complex porous structures capable of retaining small viruses such as parvoviruses having 18-24 nm in diameter by at least 99.99 % corresponding to a log10 reduction value (LRV) >= 4. At the same time, typical product molecules like monomeric IgG-type monoclonal antibodies, having diameters of 9-12 nm, need to be transmitted by more than 95 %. Exhibiting pore sizes (nominally 20 nm) within the same magnitude of both product and contaminant species renders the separation task that VFMs fulfil intensely sophisticated. For comparison, other size-based unit operations utilizing membranes, such as microfiltration, separate species differing by at least one order of magnitude in hydrodynamic diameter. This high demand for selectivity renders the development and manufacturing of VFMs a challenging task. Besides the obligatory virus retention performance, the main application relevant performance characteristics of a VFM are the water/buffer permeability and the fouling robustness. From a material scientific perspective, these application characteristics are closely linked to the pore size distribution (PSD) in the separation-active layer (SAL), the pore size gradient (PSG) along the membrane thickness and the characteristics of the membrane surface. In ...
Membranes for virus removal by size exclusion ; Membranen zur Entfernung von Viren mittels Größenausschluss
Kosiol, Peter (author) / Ulbricht, Mathias
2018-08-07
Theses
Electronic Resource
English
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