Predictive stability in biopharmaceuticals and vaccines: Perspectives and recommendations towards accelerating patient access.
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| Title: | Predictive stability in biopharmaceuticals and vaccines: Perspectives and recommendations towards accelerating patient access. |
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| Authors: | Skomski D; Merck & Co., Inc., Analytical R&D, 126 E Lincoln Ave, Rahway, NJ, USA. Electronic address: daniel.skomski@merck.com., Ji A; Genentech, Pharmaceutical Development, 1 DNA Way, South San Francisco, CA 94080., Kuzman D; Novartis Ltd, Biologics Drug Product Development, Technical Research and Development, Kolodvorska 27, 1234 Menges, Slovenia., Clenet D; Sanofi Pasteur, Global Bioprocess Development, Vaccine CMC Development & Supply, 1541 Avenue Marcel Merieux, Marcy-L' Etoile 69280, France., Hieb A; Genentech, Pharmaceutical Development, 1 DNA Way, South San Francisco, CA 94080., Roberts SW; Novo Nordisk A/S, Regulatory Affairs, Chemistry, Manufacturing and Controls, Søborg, DK., Berry J; Eli Lilly and Company, Global Regulatory Affairs, CMC, Lilly Corporate Center, Indianapolis, IN 46285., Lentes C; F. Hoffmann-La Roche Ltd., Pharmaceutical Development & Supplies, Pharmaceutical Technical Development Biologics Europe, Grenzacherstrasse 124, 4070 Basel, Switzerland., Weusten J; MSD, Center for Mathematical Sciences, Vollenhovermeer 2, 5347 JV, Oss, The Netherlands., MacArthur K; Pfizer, Inc., Global CMC Vaccines, 66 Hudson Boulevard East, NY, NY 10001, USA., Charles AS; Pfizer, Inc., Analytical Research & Development, 875 Chesterfield Parkway West, Chesterfield, MO 63017, USA., Ahlstrom B; Amgen Inc., Quality, One Amgen Center Drive, Thousand Oaks, CA 91320., Auguste-Bowler S; Novo Nordisk A/S, Rare Diseases., Chinn L; Sanofi Pasteur, Regulatory Affairs, Sanofi Pasteur, 1755 Steeles Ave W, North York, Ontario, M2R 3T4, Canada., Boehrer A; Boehringer Ingelheim Pharma GmbH & Co. KG, Global Development CMC Biologicals, 88397 Biberach/Riss, Germany., Feng S; AbbVie Inc., Department of Development Sciences, 2525 Dupont Dr., Irvine, CA, USA., Thompson C; Astra Zeneca, CMC Statistics, Data Science and Modelling, Biopharmaceutical Development, Gaithersburg, MD., Francq B; GSK, Technical R&D, 89 rue de l'Institut, 1330 Rixensart, Belgium., Laue C; Merck Healthcare KGaA, Analytical Development & Innovation NCE, Frankfurter Str. 250, 64293 Darmstadt, Germany., Bury ME; Novartis Pharma AG, Regulatory Affairs CMC Biologics, CH-4056 Basel, Switzerland., Rauk AP; Development Statistics, Eli Lilly and Company, Lilly Corporate Center, 893 Delaware St, Indianapolis, IN 46225, USA., Cui T; Johnson & Johnson, Drug Product Development & Delivery, Archimedesweg 30, 2333CN, Leiden, NL., Scholfield M; Astra Zeneca, Dosage Form Design & Development, BioPharmaceutical Development, BioPharmaceuticals R&D, Gaithersburg, MD 20878, USA., Meleties M; Regeneron Pharmaceuticals, Inc., Formulations Development, 777 Old Saw Mill River Road, Tarrytown, NY, 10591 USA., Kronimus Y; Boehringer Ingelheim Pharma GmbH & Co. KG, Global Development CMC Biologicals, 88397 Biberach/Riss, Germany., Jakka K; GSK, Investigator Analytical Development, 1250 S. Collegeville Road, Collegeville, PA 19426-0989, United States., Boncina M; Novartis Ltd, Biologics Drug Product Development, Technical Research and Development, Kolodvorska 27, 1234 Menges, Slovenia., Burgers P; Johnson & Johnson, Clinical Stability Studies., Krug E; Eli Lilly and Company, Bioproduct Development, Lilly Corporate Center, 893 Delaware St, Indianapolis, IN 46225, USA., Segarra E; Amgen Inc., Quality, One Amgen Center Drive, Thousand Oaks, CA 91320., Wu J; Regeneron Pharmaceuticals, Inc., Formulations Development, 777 Old Saw Mill River Road, Tarrytown, NY, 10591 USA., Kalonia C; Astra Zeneca, Dosage Form Design & Development, BioPharmaceutical Development, BioPharmaceuticals R&D, Gaithersburg, MD 20878, USA., Lowney D; Johnson & Johnson, Clinical Stability Studies. |
| Source: | Journal of pharmaceutical sciences [J Pharm Sci] 2025 Aug; Vol. 114 (8), pp. 103873. Date of Electronic Publication: 2025 Jun 13. |
| Publication Type: | Journal Article; Review |
| Journal Info: | Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6017 (Electronic) Linking ISSN: 00223549 NLM ISO Abbreviation: J Pharm Sci Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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