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Their broader adoption in clinical and regulated settings, however, is hindered by regulatory requirements related to data integrity, regulatory compliance, reproducibility, and scalability. To address this gap, we developed NNclinSSOAP (Novo Nordisk Clinical Single-cell Spatial Omics Analytical Pipeline)\u2014a modular, GxP-ready end-to-end computational pipeline that combines established single-cell workflows with a new Nextflow pipeline for Spatial Transcriptomics. NNclinSSOAP transforms RNA sequencing and Xenium spatial data into integrated, annotated single-cell objects and spatially resolved tissue maps. Designed to support mechanistic studies and clinical endpoint generation, it enables traceable and reproducible processing of large-scale datasets, scalable for use in HPC environments. Here, we provide a step-by-step demo case for using NNclinSSOAP that can be executed within 1.5 h on a standard laptop. All code and data are available open-source.<\/jats:p>","DOI":"10.34133\/csbj.0164","type":"journal-article","created":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T00:17:16Z","timestamp":1782087436000},"update-policy":"https:\/\/doi.org\/10.34133\/aaas_crossmark_01","source":"Crossref","is-referenced-by-count":1,"title":["GxP-Ready Single-Cell RNA-seq and Spatial Transcriptomics End-to-End Pipeline for Clinical Research"],"prefix":"10.34133","volume":"35","author":[{"given":"Amaya","family":"Zaratiegui","sequence":"first","affiliation":[{"name":"Novo Nordisk A\/S","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy","family":"Burfield","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helle Rus","family":"Povlsen","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mart\u00edn E.","family":"Garc\u00eda Sol\u00e1","sequence":"additional","affiliation":[{"name":"ZS Associates, ZS Discovery","place":["Argentina"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrian","family":"Czaban","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0908-0169","authenticated-orcid":true,"given":"Keng","family":"Soh","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0614-0373","authenticated-orcid":true,"given":"Vivek","family":"Das","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"221","published-online":{"date-parts":[[2026,7,14]]},"reference":[{"issue":"18","key":"e_1_3_3_2_2","doi-asserted-by":"crossref","DOI":"10.3390\/ijms241813744","article-title":"Single-nucleus RNA-Seq: Open the era of great navigation for FFPE tissue","volume":"24","author":"Guo Y","year":"2023","unstructured":"Guo Y, Wang W, Ye K, He L, Ge Q, Huang Y, Zhao X. 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