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A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products.
Hubert, Mario; Yang, Dennis T; Kwok, Stanley C; Rios, Anacelia; Das, Tapan K; Patel, Ankit; Wuchner, Klaus; Antochshuk, Valentyn; Junge, Friederike; Bou-Assaf, George M; Cao, Shawn; Saggu, Miguel; Montrond, Luis; Afonina, Nataliya; Kolhe, Parag; Loladze, Vakhtang; Narhi, Linda.
Affiliation
  • Hubert M; Analytical Development, Celgene, Summit, New Jersey 07901. Electronic address: mhubert@celgene.com.
  • Yang DT; Biopharmaceutical Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285.
  • Kwok SC; Department of Process Sciences, Formulation and Drug Product Sciences, Seattle Genetics, Bothell, Washington 98021.
  • Rios A; Joint Particle Lab, Pharma Technical Development Europe (Biologics) Analytics (PTDE-A), F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Das TK; Methods & Analytical Development, Bristol-Myers Squibb, New Brunswick, New Jersey 08901.
  • Patel A; Early Stage Pharmaceutical Development, Genentech, South San Francisco, California 94080.
  • Wuchner K; Janssen Research & Development, DPDS BioTD Analytical Development, Schaffhausen, Switzerland.
  • Antochshuk V; Sterile Formulation Sciences, Merck & Co., Inc., Kenilworth, New Jersey 07033.
  • Junge F; Analytical Innovation and Mass Spectrometry, Abbvie Deutschland GmbH und Co.KG, Ludwigshafen, Germany.
  • Bou-Assaf GM; Protein & Gene Therapy Biophysical Characterization, Analytical Development - Engineering & Technology, Biogen, Cambridge, Massachusetts 02142.
  • Cao S; Process Development, Amgen, Thousand Oaks, California 91320.
  • Saggu M; Early Stage Pharmaceutical Development, Genentech, South San Francisco, California 94080.
  • Montrond L; Analytical Development, Takeda Pharmaceuticals, Cambridge, Massachusetts 02139.
  • Afonina N; Retired, Doylestown, Pennsylvania 18901.
  • Kolhe P; BTx Pharm Sci, Pharmaceutical Research and Development, Pfizer, Andover, Massachusetts 01810.
  • Loladze V; CMC Analytical, R&D Medicinal Science & Technology, GSK, Collegeville, Pennsylvania 19426.
  • Narhi L; Process Development, Amgen, Thousand Oaks, California 91320.
J Pharm Sci ; 109(1): 830-844, 2020 01.
Article de En | MEDLINE | ID: mdl-31647951
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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Protéines / Technologie pharmaceutique / Nanotechnologie Type d'étude: Clinical_trials / Guideline Limites: Humans Pays/Région comme sujet: America do norte / Europa Langue: En Journal: J Pharm Sci Année: 2020 Type de document: Article
Texte intégral
Ajouter à My VHL
Imprimer
XML
PubMed Links
Recherche sur Google

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Protéines / Technologie pharmaceutique / Nanotechnologie Type d'étude: Clinical_trials / Guideline Limites: Humans Pays/Région comme sujet: America do norte / Europa Langue: En Journal: J Pharm Sci Année: 2020 Type de document: Article