Seema Kumar

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Publications (6)

• 2022 White Paper on Recent Issues in Bioanalysis: Fda Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, Lnp & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, Ada Affinity, Risk-Based Approaches, Ngs, Qpc…
  Bioanalysis 2023 DOI: 10.4155/bio-2023-0135
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• Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development
  The AAPS Journal 2023 DOI: 10.1208/s12248-023-00820-7
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• Assay development considerations to improve drug tolerance in direct competitive ligand binding neutralizing antibody assays, pretreatment strategies
  Journal of Immunological Methods 2023 DOI: 10.1016/j.jim.2023.113484
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• Anti-drug Antibody Sample Testing and Reporting Harmonization
  The AAPS Journal 2022 DOI: 10.1208/s12248-022-00762-6
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• Abstract 5284: M1231 is a bispecific anti-MUC1xEGFR antibody-drug conjugate designed to treat solid tumors with MUC1 and EGFR co-expression
  Cancer Research 2022 DOI: 10.1158/1538-7445.am2022-5284
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• Abstract 5423: Translational PK/PD/efficacy modeling and efficacious human dose prediction for a first-in-class MUC1-EGFR (M1231) bispecific antibody drug conjugate
  Cancer Research 2022 DOI: 10.1158/1538-7445.am2022-5423
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