NIST only participates in the February and August reviews.
This program explores the development and evaluation of integrated measurement strategies for biopharmaceutical manufacturing using the NIST Biomanufacturing Testbed and the NISTCHO/cNISTmAb model system. Projects are focused on investigating the complex interplay between mammalian cell biology and process conditions and protocols, including temperature, dissolved oxygen, pH, and feeding strategies, and their collective impact on cell growth and productivity, and on final product quality. Projects could also explore the development and application of new Process Analytical Technology (PAT) tools for real-time monitoring and control of critical process parameters. Furthemore, the program scope extends to downstream purification processes, offering a platform to evaluate new technologies for impurity removal, process robustness, and the impact of upstream conditions on the final product attributes. Ultimately, this program aims to integrate knowledge from these project areas within a centralized testbed environment to develop improved biopharmaceutical manufacturing processes, advanced monitoring and control tools and strategies, and standardized approaches for manufacturing operations.
References
(1) Cleveland MH, Karageorgos IL, Marino JP, Tarlov MJ, Yandrofski KS, Zangemeister RA, Kelman Z. Recommended nomenclature convention for the NISTCHO cell line and its product monoclonal antibody, cNISTmAb. MAbs. 2025 Dec;17(1):2490789
(2) Dahodwala H, Hodzic I, Slesarev A, Cutak B, Kuzin A, Lal R, Liu J, Mahon J, Narasimhan RL, Onuska J, Ravellette J, Reger K, Sakurada S, Stewart F, Borgsculte T, Cote C, Lee KH, O'Dell WB, Kelman Z, Anderson BA. Development and Characterization of the NISTCHO Reference Cell Line. Biotechnol J. 2025 May;20(5);e70012
Mammalian cell culture;Biomanufacturing;Bioreactors;Upstream processing;Downstream purification;Process analytical technologies (PAT);Metabolite analysis
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