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Advances in the development of cell lines, cell culture processes, and analytical technologies have enabled the generation of more homogeneous stable pool populations with increased productivity. Leveraging the experience gained from the COVID\u201019 product development, the strategic use of stable cell pools or a pool of clones for early\u2010stage non\u2010GMP material generation and process development has proven transformative in significantly reducing the CMC timeline to investigational new drug (IND). This study provides a comprehensive comparison of bioprocess performance and product quality attributes of materials produced from stable pools or a pool of clones (toxicology study materials) versus those from clonally derived cells (GMP clinical batches) across six First\u2010in\u2010Human (FIH) programs involving mAbs, bsAb, and Fc\u2010fusion proteins. The results demonstrate a strong alignment and the feasibility of using protein materials from stable pools or a pool of clones in toxicology studies. In conclusion, utilizing non\u2010clonal CHO cell\u2010derived material for preclinical studies offers a strategic approach that can be broadly applied to complex molecules across various disease areas, even under standard regulatory filings, accelerating the path to clinical trials.<\/jats:p>","DOI":"10.1002\/btpr.70040","type":"journal-article","created":{"date-parts":[[2025,5,19]],"date-time":"2025-05-19T05:34:36Z","timestamp":1747632876000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Accelerating <scp>IND<\/scp>\u2010enabling toxicology studies using protein products from stable pools or pools of clones in Chinese hamster ovary cells"],"prefix":"10.1002","volume":"41","author":[{"given":"Yiwen","family":"Jiang","sequence":"first","affiliation":[{"name":"WuXi Biologics  Shanghai 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