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Current Industry Best Practice on in-use Stability and Compatibility Studies for Biological Products.

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第一作者: Markus,Blümel
第一单位: Novartis Pharma AG, Biologics Analytical Development, Lichtstrasse 35, CH-4056 Basel, Switzerland. Electronic address: markus.bluemel@novartis.com.
作者单位: Novartis Pharma AG, Biologics Analytical Development, Lichtstrasse 35, CH-4056 Basel, Switzerland. Electronic address: markus.bluemel@novartis.com. [1] Seagen Inc., Pharmaceutical Sciences, 21717 30th Drive S.E., Building 3. Bothell, WA, 98021, USA. Electronic address: liujing97@gmail.com. [2] Genentech (A Member of the Roche Group), Pharmaceutical Development, 1 DNA Way, South San Francisco, CA, 94080, USA. [3] Pfizer; Biotherapeutics Pharmaceutical Sciences, 1 Burtt Road, Andover, MA 01810, USA. [4] F. Hoffmann-La Roche Ltd., Pharmaceutical Development & Supplies, PTD Biologics Europe, Grenzacherstrasse 124, CH, 4070 Basel, Switzerland. [5] Amgen Inc., Process Development, 360 Binney St., Cambridge, MA, 02141, USA. [6] GSK, Strategic External Development, Sterile Drug Product Operations, 1250 S. Collegeville Road Collegeville, PA, 19426, USA. [7] Teva Branded Pharmaceutical Products, Drug Product Development and Operations, 145 Brandywine Pkwy, West Chester, PA 19380, USA. [8] AstraZeneca, Dosage Form Design and Development, Aaron Klug Building, Granta Park, Cambridge, Cambridgeshire, CB21 6GH, UK. [9] AbbVie Inc., North Chicago, IL, USA. [10] Biogen, Biologics Drug Product, 225 Binney Street, Cambridge, MA, 02142, USA. [11] Eli Lilly and Company, Bioproduct Research and Development, Indianapolis, IN, 46285, USA. [12] Sanofi, Biologics Drug Product Development, 1 impasse des ateliers, 94403 Vitry-Sur-Seine, France. [13] AstraZeneca, Dosage Form Design and Development, One Medimmune Way, Gaithersburg, MD, 20878, USA. [14] Amgen Inc., Product Quality, 40 Technology Way, West Greenwich, RI, 02817, USA. [15] Novartis Pharma AG, Biologics Analytical Development, Biochemiestrasse 10, 6336 Langkampfen, Austria. [16] Sanofi, Biologics Drug Product Development, Industriepark Höchst, D-65926 Frankfurt am Main, Germany. [17]
DOI 10.1016/j.xphs.2023.05.002
PMID 37160227
发布时间 2023-08-22
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