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Fc fusion protein (Fc-Fusion) has a complex and diverse molecular structure, and may contain glycosylation modification sites at amino acid 297 of its Fc fragment and the Fab region of some molecules. Moreover, its biological ligands are structurally diverse, and their glycosylation modifications may also be complex, usually involving multiple N-glycan and O-glycan sites and a large number of…

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Risk analysis is used for the evaluation of potential risk problems that could be encountered in connection with the use of a medical device. Biological hazards, risk characterization, and toxicological risk assessment are required to ensure the safety of a novel medical device and meet the requirements of marketplaces.   Standard for Risk Assessments Risk assessments…

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Irritation represents local tissue inflammation response to chemicals, without a systemic immunological component, and irritation is characterized by inflammation, redness, swelling, heat, or pain. Irritation testing is used to assess the potential of a medical device to cause an immediate irritation reaction in the skin, mucosal, or ocular tissues following a single or repeated exposure…

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