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An Interlaboratory Study to Identify Potential Visible Protein-Like Particle Standards.
Telikepalli, Srivalli N; Carrier, Michael J; Ripple, Dean C; Barnett, Greg; Bhirde, Ashwinkumar; Bolton, Donna; Bou-Assaf, George M; Ferrari, Erica; Leigh, Scott; Levitskaya-Seaman, Sophia; Menzen, Tim; Nikels, Felix; Riley, Anna; Saggu, Miguel; Sahni, Neha; Vernooij, Eric; Wuchner, Klaus.
Afiliación
  • Telikepalli SN; NIST, Biomolecular Measurement Division, Maryland, Gaithersburg, USA. srivalli.telikepalli@nist.gov.
  • Carrier MJ; NIST, Biomolecular Measurement Division, Maryland, Gaithersburg, USA.
  • Ripple DC; NIST, Biomolecular Measurement Division, Maryland, Gaithersburg, USA.
  • Barnett G; Currently at Lundbeck Seattle Biopharmaceuticals, Inc., Bothell, Washington, USA.
  • Bhirde A; Food and Drug Administration, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.
  • Bolton D; Porton Biopharma Ltd., Salisbury, UK.
  • Bou-Assaf GM; Biogen, Analytical Development, Cambridge, Massachusetts, USA.
  • Ferrari E; Sanofi, BioAnalytics Germany, Characterization, Frankfurt Am Main, Germany.
  • Leigh S; FibroGen, Inc., Analytical Development, San Francisco, California, USA.
  • Levitskaya-Seaman S; MacroGenics, Inc., Analytical Sciences, BPD, Rockville, Maryland, USA.
  • Menzen T; Coriolis Pharma Research Gmbh, Martinsried, Germany.
  • Nikels F; Boehringer Ingelheim Pharma GmbH & Co., Innovation Unit, Biberach, KG, Germany.
  • Riley A; Eli Lilly and Company, Global Quality Laboratories, Indianapolis, Indiana, USA.
  • Saggu M; Genentech, Inc., Pharmaceutical Development, San Francisco, California, USA.
  • Sahni N; Currently at MacroGenics, Drug Product Sciences, Drug Product Development, Rockville, Maryland, USA.
  • Vernooij E; AstraZeneca, Global Operations Biologics, Nijmegen Manufacturing Facility, Nijmegen, Netherlands.
  • Wuchner K; Janssen R&D, DPDS BTDS Analytical Development, Schaffhausen, Switzerland.
AAPS PharmSciTech ; 24(1): 18, 2022 Dec 16.
Article en En | MEDLINE | ID: mdl-36526853
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Proteínas Tipo de estudio: Guideline / Qualitative_research Idioma: En Año: 2022 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Proteínas Tipo de estudio: Guideline / Qualitative_research Idioma: En Año: 2022 Tipo del documento: Article