Publications by authors named "Sarah Hosback"
CSL040 is a soluble, recombinant fragment of the complement receptor 1 (CR1) extracellular domain that acts as an inhibitor of all three pathways of the complement system. Systemic toxicity, toxicokinetics (TK), and pharmacodynamics (PD) of CSL040 were assessed in two-week intravenous (IV) bolus studies in Han Wistar rats and cynomolgus monkeys. Recovery from any effects was evaluated during a four-week recovery period.
View Article and Find Full Text PDFArticle Synopsis
- Immunogenicity testing helps understand the immune response to protein therapies, and neutralizing antibody (NAb) assays are key to characterizing anti-drug antibody responses.
- A group of NAb assay experts has created standardized reporting recommendations to streamline communication and facilitate regulatory submissions.
- The document outlines essential components for NAb sample analysis reports, though it does not cover the interpretation of immunogenicity data related to safety and efficacy.