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Residue-Specific Impact of EDTA and Methionine on Protein Oxidation in Biotherapeutics Formulations Using an Integrated Biotherapeutics Drug Product Development Workflow.
Thakkar, Santosh V; Rodrigues, Danika; Zhai, Bo; Banton, Dwaine; Somani, Sandeep; Javidi, Alex; Mahan, Andrew; Ember, Stuart; DeGrazio, Dominick; Ganguly, Subinay; Amin, Ketan; Nanda, Hirsh.
Afiliação
  • Thakkar SV; Drug Product Development, BioTherapeutics Development and Supply, Janssen Research and Development (Janssen R&D), Malvern, PA 19355, USA; Protein Therapeutics API Development, BioTherapeutics Development and Supply, Janssen Research and Development (Janssen R&D), Spring House, PA 19477, USA.
  • Rodrigues D; Drug Product Development, BioTherapeutics Development and Supply, Janssen Research and Development (Janssen R&D), Malvern, PA 19355, USA.
  • Zhai B; Protein Therapeutics API Development, BioTherapeutics Development and Supply, Janssen Research and Development (Janssen R&D), Spring House, PA 19477, USA.
  • Banton D; Translational Medicine and Early Development Statistics, Janssen Research and Development (Janssen R&D), Spring House, PA 19477, USA.
  • Somani S; Discovery Sciences, Janssen Research and Development (Janssen R&D), Spring House, PA 19477, USA.
  • Javidi A; Data Sciences, Strategy and Operations, Janssen Research and Development (Janssen R&D), Spring House, PA 19477, USA.
  • Mahan A; Protein Therapeutics API Development, BioTherapeutics Development and Supply, Janssen Research and Development (Janssen R&D), Spring House, PA 19477, USA.
  • Ember S; Drug Product Development, BioTherapeutics Development and Supply, Janssen Research and Development (Janssen R&D), Malvern, PA 19355, USA.
  • DeGrazio D; Drug Product Development, BioTherapeutics Development and Supply, Janssen Research and Development (Janssen R&D), Malvern, PA 19355, USA.
  • Ganguly S; Protein Therapeutics API Development, BioTherapeutics Development and Supply, Janssen Research and Development (Janssen R&D), Spring House, PA 19477, USA.
  • Amin K; Drug Product Development, BioTherapeutics Development and Supply, Janssen Research and Development (Janssen R&D), Malvern, PA 19355, USA.
  • Nanda H; Protein Therapeutics API Development, BioTherapeutics Development and Supply, Janssen Research and Development (Janssen R&D), Spring House, PA 19477, USA. Electronic address: hnanda@its.jnj.com.
J Pharm Sci ; 112(2): 471-481, 2023 02.
Article em En | MEDLINE | ID: mdl-36130676
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Racemetionina / Metionina Tipo de estudo: Prognostic_studies Idioma: En Revista: J Pharm Sci Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Racemetionina / Metionina Tipo de estudo: Prognostic_studies Idioma: En Revista: J Pharm Sci Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos