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. |
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| 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 |
| ISSN: | 1873-3441 |
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| DOI: | 10.1016/j.ejpb.2023.11.016 |
