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Detection of innate immune response modulating impurities (IIRMI) in therapeutic peptides and proteins: Impact of excipients.
Thacker, Seth G; Her, Cheng; Kelley-Baker, Logan; Ireland, Derek D C; Manangeeswaran, Mohanraj; Pang, Eric S; Verthelyi, Daniela.
Afiliação
  • Thacker SG; Laboratory of Immunology, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States.
  • Her C; Laboratory of Immunology, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States.
  • Kelley-Baker L; Laboratory of Immunology, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States.
  • Ireland DDC; Laboratory of Immunology, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States.
  • Manangeeswaran M; Laboratory of Immunology, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States.
  • Pang ES; Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States.
  • Verthelyi D; Laboratory of Immunology, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States.
Front Immunol ; 13: 970499, 2022.
Article em En | MEDLINE | ID: mdl-36148237
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Excipientes Idioma: En Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Excipientes Idioma: En Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos