Foot-and-mouth disease (FMD) is a vesicular disease of cloven-hoofed animals with devastating economic implications. The current FMD vaccine, routinely used in enzootic countries, requires at least 7 days to induce protection. However, FMD vaccination is typically not recommended for use in non-enzootic areas, underscoring the need to develop new fast-acting therapies for FMD control during outbreaks.
View Article and Find Full Text PDFARX788 is an anti-HER2 antibody drug conjugate (ADC) developed using Ambrx proprietary Engineered Precision Biologics technology. The manufacturing process of ARX788 has been optimized during the course of early to late-phase clinical development. A comprehensive evaluation of side-by-side comparability between pre- and post-change process for ARX788 drug substance and drug product from a quality perspective was conducted based on ICH Q5E guidelines consisting of batch release assays, physicochemical and biophysical characterization, biological characterization, and forced degradation studies.
View Article and Find Full Text PDFIntimate partner violence (IPV) is a significant public health problem among college students and many students have difficulty identifying unhealthy and abusive behaviors. The aims of this mixed methods study are to: (a) create an inclusive tool that illustrates the power and control experiences of a diverse group of young adult college students, (b) ensure a broad scope of tactics are illustrated (related to technology and different types of relationships), and (c) measure the experience of these tactics, including how IPV knowledge, attitudes, and self-efficacy are influenced by a more inclusive tool. In Phase I, semi-structured interviews were conducted with students (n = 33) and staff (n = 10) at campus sexual assault centers at the three University of Michigan (UM) campuses to explore power and control tactics utilized by perpetrators on college campuses.
View Article and Find Full Text PDFFirst-generation antibody-drug conjugates (ADC) are heterogeneous mixtures that have shown clinical benefit, but generally exhibited safety issues and a narrow therapeutic window due, in part, to off-target toxicity caused by ADC instability. ARX788 is a next-generation, site-specific anti-HER2 ADC that utilizes a unique nonnatural amino acid-enabled conjugation technology and a noncleavable Amberstatin (AS269) drug-linker to generate a homogeneous ADC with a drug-to-antibody ratio of 1.9.
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