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A Cell-Based Reporter Gene Assay for TNF-α Neutralization: Analytical Qualification and Application to Adalimumab and Its Biosimilars

2025-12-05

Abstract excerpt

<title>Abstract</title> <p> <bold>Purpose:</bold> To qualify a mechanism‑of‑action (MoA)–reflective reporter gene assay (RGA) for measuring the biological activity of adalimumab (Humira) and its biosimilars, supporting assessment of product quality, comparability, and functional consistency across the product lifecycle. <bold>Methods:</bold> The assay evaluates TNF‑α neutralization by monitoring inhibition of...

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Literature Corpus work
9de68f7b-05b7-5476-b4f9-dea67eff7532
DOI
10.21203/rs.3.rs-8273462/v1
Open publication

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A Cell-Based Reporter Gene Assay for TNF-α Neutralization: Analytical Qualification and Application to Adalimumab and Its BiosimilarsDOI 10.21203/rs.3.rs-8273462/v1
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