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Risk-based approach to setting sterile filtration microbial bioburden limits - Focus on biotech-derived products.

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Title: Risk-based approach to setting sterile filtration microbial bioburden limits - Focus on biotech-derived products.
Authors: Bechtold-Peters K; Novartis Pharma AG, Basel, Switzerland. Electronic address: Peters@novartis.com., Chang S; AstraZeneca, Gaithersburg, USA., Lennard AC; Amgen Limited, Uxbridge, UK., Mateffy J; Amgen, Thousand Oaks, USA., Murphy M; Eli Lilly & Co., Kinsale, Ireland., Perry M; Pfizer Ireland Pharmaceuticals, Dublin, Ireland., Roesti D; Novartis Pharma AG, Stein, Switzerland., Singer DC; Ecolab Life Sciences, St. Paul, USA., Wintzingerode FV; Genentech, Inc. A Member of the Roche Group, South San Francisco, USA., Yang H; Fate Therapeutics, San Diego, USA.
Source: European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V [Eur J Pharm Biopharm] 2024 May; Vol. 198, pp. 114151. Date of Electronic Publication: 2023 Dec 01.
Publication Type: Journal Article
Journal Info: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 9109778 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-3441 (Electronic) Linking ISSN: 09396411 NLM ISO Abbreviation: Eur J Pharm Biopharm Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Risk-based approach to setting sterile filtration microbial bioburden limits - Focus on biotech-derived products.
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  Data: <searchLink fieldCode="AU" term="%22Bechtold-Peters+K%22">Bechtold-Peters K</searchLink>; Novartis Pharma AG, Basel, Switzerland. Electronic address: Peters@novartis.com.<br /><searchLink fieldCode="AU" term="%22Chang+S%22">Chang S</searchLink>; AstraZeneca, Gaithersburg, USA.<br /><searchLink fieldCode="AU" term="%22Lennard+AC%22">Lennard AC</searchLink>; Amgen Limited, Uxbridge, UK.<br /><searchLink fieldCode="AU" term="%22Mateffy+J%22">Mateffy J</searchLink>; Amgen, Thousand Oaks, USA.<br /><searchLink fieldCode="AU" term="%22Murphy+M%22">Murphy M</searchLink>; Eli Lilly & Co., Kinsale, Ireland.<br /><searchLink fieldCode="AU" term="%22Perry+M%22">Perry M</searchLink>; Pfizer Ireland Pharmaceuticals, Dublin, Ireland.<br /><searchLink fieldCode="AU" term="%22Roesti+D%22">Roesti D</searchLink>; Novartis Pharma AG, Stein, Switzerland.<br /><searchLink fieldCode="AU" term="%22Singer+DC%22">Singer DC</searchLink>; Ecolab Life Sciences, St. Paul, USA.<br /><searchLink fieldCode="AU" term="%22Wintzingerode+FV%22">Wintzingerode FV</searchLink>; Genentech, Inc. A Member of the Roche Group, South San Francisco, USA.<br /><searchLink fieldCode="AU" term="%22Yang+H%22">Yang H</searchLink>; Fate Therapeutics, San Diego, USA.
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  Data: <searchLink fieldCode="JN" term="%229109778%22">European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V</searchLink> [Eur J Pharm Biopharm] 2024 May; Vol. 198, pp. 114151. <i>Date of Electronic Publication: </i>2023 Dec 01.
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        Value: 10.1016/j.ejpb.2023.11.016
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        StartPage: 114151
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              Text: 2024 May
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