Nitrosamines are potential mutagens and need to be controlled in human drug products. Recently, nitrosamine contamination of high-profile drugs has prompted numerous recalls, and increased regulatory assessments for marketed products.
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Cryo-electron microscopy (cryoEM) is a Nobel Prize-winning technique for solving high-resolution three-dimensional structures of biological molecules such as proteins, that is used for structure-based drug design. Key to the success of cryoEM are significant advances in high performance computer vision and machine learning algorithms, used to extract information from large numbers of noisy 2D microscope images and compute and refine 3D structures of target proteins in near-native states.
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Peptide and oligonucleotide drugs are versatile therapeutics with a growing range of applications and many similarities in terms and of manufacturing and regulation.
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Many global pharmaceutical companies are often faced with a volume of content in the field that has grown to a point where the quality of that labeling is unknown. Assessment of what exists and correcting the process to avoid pitfalls in the future can be a daunting task.
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