https://pages.htgaa.org/2026b/tania-araceli-barreda-galvez/week-01-hw-project-ideas/index.htmlHTBAA Homework #1 1. What you would like to biomanufacture and why? Target product: a single-domain antibody fragment (nanobody, VHH) directed against PD-L1, intended for use as an immunohistochemistry (IHC) diagnostic reagent, designed to integrate with an automated digital quantification workflow. Why: In triple-negative breast cancer (TNBC), eligibility for atezolizumab depends on a specific assay, SP142, which evaluates PD-L1 expression in tumor-infiltrating immune cells using a threshold of just 1%. This type of scoring presents challenges related to the pathologist’s visual assessment and inter-pathologist agreement when evaluating low thresholds in tissue. Without prior training, visual interpretation tends to be more subjective, and while training improves outcomes, it does not eliminate reliance on individual visual interpretation (Kim et al., 2021). This substantial variability among pathologists when evaluating immunological biomarkers has direct implications for therapeutic decisions (Van Bockstal et al., 2023). I have encountered this type of problem firsthand in my current position at a pathology laboratory in Peru. The accuracy of a reagent is not merely a technical issue; rather, it determines whether a patient has access to treatment. A nanobody produced through a standardized cell-free process, combined with an automated digital quantification system rather than a pathologist’s visual reading, could offer a more objective alternative to the current manual scoring. As far as I can tell from the literature, this combination has not been specifically explored for this problem.Hugoen