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Considerations for the Terminal Sterilization of Oligonucleotide Drug Products.
DeCollibus, Daniel Paul; Searcy, Justin; Tivesten, Anna; Akhtar, Nadim; Lindenberg, Christian; Abarrou, Nounja; Pradhan, Sujana; Fiandaca, Maggie; Franklin, Jenny; Govindan, Geetha; Liu, Hung-Yi; Royle, David; Soo, Patrick Lim; Storch, Kirsten.
Afiliação
  • DeCollibus DP; Drug Product Technology and Engineering, Amgen, Cambridge, Massachusetts, USA.
  • Searcy J; Pharmaceutical Development, Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.
  • Tivesten A; CVRM CMC Projects, Pharmaceutical Sciences, AstraZeneca R&D, Gothenburg, Sweden.
  • Akhtar N; New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, United Kingdom.
  • Lindenberg C; Global Drug Development, Technical Research & Development, Novartis Pharma AG, Basel, Switzerland.
  • Abarrou N; Global Drug Development, Technical Research & Development, Novartis Pharma AG, Basel, Switzerland.
  • Pradhan S; GSK, Strategic External Development, Analytical Development, Collegeville, Pennsylvania, USA.
  • Fiandaca M; GSK, Strategic External Development, Analytical Development, Collegeville, Pennsylvania, USA.
  • Franklin J; CMC Regulatory Affairs, Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.
  • Govindan G; Pharmaceutical Operations & Technology, Biogen, Cambridge, Massachusetts, USA.
  • Liu HY; Pharmaceutical Operations & Technology, Biogen, Cambridge, Massachusetts, USA.
  • Royle D; New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, United Kingdom.
  • Soo PL; Pharmaceutical Research and Development, BioTherapeutics Pharmaceutical Sciences, Pfizer, Andover, Massachusetts, USA.
  • Storch K; Pharma Technical Development, Roche Diagnostics GmbH, Mannheim, Germany.
Nucleic Acid Ther ; 33(3): 159-177, 2023 06.
Article em En | MEDLINE | ID: mdl-36787481
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Oligonucleotídeos / Preparações Farmacêuticas / Esterilização Tipo de estudo: Guideline Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Oligonucleotídeos / Preparações Farmacêuticas / Esterilização Tipo de estudo: Guideline Idioma: En Ano de publicação: 2023 Tipo de documento: Article