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Closed-Loop CHO-K1 Bioreactor Digital Twin, ISPE A-Mab QbD Design Space, USP <1079.2> VTB/MKT Analyzer & Six Sigma SPC Suite validated under FDA CSA (2026) & 21 CFR Part 11.
Python framework for structural and practical identifiability analysis of a 13-parameter Multi-Cell Line CHO kinetic model using SVD-ROSM, Monte Carlo simulations, and t-value based parameter fixing.