A biologic medical product that is almost an identical copy of an original product that is manufactured by a different company.
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The release of a recent EMA reflection paper, aligning with FDA and WHO positions, has resulted in a renewed focus on the central role of pharmacokinetic (PK) data, the primary status of ana...
APR 03, 2024 | 9:00 AM
C.E. CREDITS
Cultured mammalian cells, particularly Chinese hamster ovary (CHO) cells are widely used in the biotechnology industry for production of a wide range of therapeutics, predominantly monoclona...
Although affinity tag methods for protein purification have greatly accelerated research in laboratories throughout the world, the presence of the tag on the purified target can modify the t...
Date: March 18, 2021 Time: 9:00am (PST), 12:00am (EST) As novel therapeutic modalities progress through development, improved analytical techniques are required to overcome characterization...
The NIST Biomanufacturing Program develops measurement science, standards, reference data and tools to support the development, manufacturing, and regulatory approval of biologic medicines....
Hydrogen-deuterium exchange mass spectrometry (HDX-MS) has developed into a powerful tool for investigating biopharmaceuticals, protein interactions, and membrane protein dynamics. Since 2010...
Two-dimensional (2D) 1H-13C methyl correlated NMR is increasingly being recognized as a powerful tool to characterize the higher order structure (HOS) of monoclonal antibody (mAb) therapeutic...