Life Sciences → Immunology and Microbiology → Immunology
Biosimilars and Bioanalytical Methods
This cluster of papers focuses on the immunogenicity of biosimilar therapeutics, including the validation of bioanalytical methods for assessing immunogenicity, the impact of manufacturing changes on immunogenicity, and the clinical outcomes and safety of switching from reference biologics to biosimilars. The use of dried blood spots for bioanalysis and the regulatory considerations for biosimilars are also prominent topics within this cluster.
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BiosimilarsImmunogenicityBioanalytical MethodsTherapeutic ProteinsDried Blood SpotsErythropoietin AntibodiesMonoclonal AntibodiesRegulatory GuidelinesBiopharmaceuticalsClinical Outcomes

