Yandrofski, K.
, Cleveland, M.
, Kelman, Z.
, Tarlov, M.
and Marino, J.
(2025),
NIST Biomanufacturing Reference Materials: Development, Applications and Impact, The Bridge, [online], https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=959777 (Accessed August 9, 2026)
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NIST Biomanufacturing Reference Materials: Development, Applications and Impact
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Abstract
Monoclonal antibody (mAb) therapeutics, currently the most successful platform class of biologic medicines, harness the naturally evolved specificity of adaptive immunity to treat a variety of conditions such as cancer, autoimmune disorders, and infectious diseases. mAbs are complex, multidomain proteins with post-translational modifications (PTMs), including N-glycosylation at a single site that can play a particularly important role in determining safety and efficacy. mAb-based therapeutics are manufactured using highly controlled bioprocesses that typically employ mammalian cells such as Chinese hamster ovary (CHO) or murine myeloma (NS0) as the production host. During process development, manufacture, formulation and product release, a wide variety of analytical technologies are used to characterize mAb therapeutics and the processes used in their manufacture. These methods are used to measure the critical quality attributes (CQAs) of a drug product related to its identity, purity, stability, potency and safety and the critical process parameters in the manufacturing process. Due to their large size and the nature of cell-based production, mAbs, like other protein-based therapeutics, are inherently complex and heterogenous and defined by determined acceptable ranges of variance in measured CQAs that correlate to performance of the therapeutic in clinical application.Citation
The Bridge
Pub Type
Journals
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Keywords
biopharmaceutical, monoclonal antibody, NISTmAb, CHO cell line, NISTCHO
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Created June 16, 2025, Updated August 6, 2026