Conversational User Interfaces (CUI) are widely used, with about 1.8 billion users worldwide in 2020. For designing and building CUI, dialogue designers have to decide on how the CUI communicates with users and what dialogue strategies to pursue (e.
View Article and Find Full Text PDFDifferent parvoviruses are used interchangeably as models in validation studies to demonstrate effective clearance of small viruses by filtration in the manufacturing of biotherapeutics. The aim of these experiments was to determine if filtration of different parvoviruses (canine parvovirus [CPV], minute virus of mice [MVM], and porcine parvovirus [PPV]) results in similar virus retention. While filtration with a Planova™ 20 N filter (mean pore size: 19 ± 2 nm) completely removed PPV and MVM from the filtrate (mean log reduction factors [LRFs] ≥5.
View Article and Find Full Text PDFBackground: Careful selection and testing of plasma reduces the risk of blood-borne viruses in the starting material for plasma-derived products. Furthermore, effective measures such as pasteurization at 60°C for 10 hours have been implemented in the manufacturing process of therapeutic plasma proteins such as human albumin, coagulation factors, immunoglobulins, and enzyme inhibitors to inactivate blood-borne viruses of concern. A comprehensive compilation of the virus reduction capacity of pasteurization is presented including the effect of stabilizers used to protect the therapeutic protein from modifications during heat treatment.
View Article and Find Full Text PDFAlpha-proteinase inhibitor (API) deficiency is a genetic condition predisposing to emphysema. Respreeza/Zemaira, a therapeutic preparation of API, is prepared from human plasma. This article describes the purity and stability of Respreeza/Zemaira and the capacity of virus and prion reduction steps incorporated into its manufacturing process.
View Article and Find Full Text PDFBackground: Beriplex P/N/Kcentra/Coaplex/Confidex is a four-factor human prothrombin complex concentrate (PCC). Here, we describe the pathogen safety profile and biochemical characteristics of an improved manufacturing process that further enhances the virus safety of Beriplex P/N.
Study Design And Methods: Samples of product intermediates were spiked with test viruses, and prions were evaluated under routine production and robustness conditions of the scale-down version of the commercial manufacturing process for their capacity to inactivate or remove pathogens.