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Immunogenicity

 

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Flow cytometry in neglected tropical diseases – a focus on leishmaniasis

10 September 2020 | By

The World Health Organization (WHO) identifies leishmaniasis as a neglected tropical disease for which new treatments are vitally needed. Leishmaniasis primarily affects people in South America, East Africa and Asia, especially those weakened by malnutrition and poverty. To help those with this disfiguring and potentially life-threatening parasitic disease, the European…

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Immunogenicity: anticipating and avoiding issues for biopharmaceutical development

21 September 2015 | By

All biopharmaceutical products are associated with an intrinsic potential to induce immune responses in treated subjects. Regulatory agencies expect sponsors to evaluate and mitigate these risks during product development, applying a strategy that addresses product- and patient-related factors. Overall, understanding and controlling immunogenicity-related risks are attainable objectives, and approvability should…