View in EDS

Predictive stability in biopharmaceuticals and vaccines: Perspectives and recommendations towards accelerating patient access.

Saved in:
Bibliographic Details
Title: Predictive stability in biopharmaceuticals and vaccines: Perspectives and recommendations towards accelerating patient access.
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
FullText Text:
  Availability: 0
Header DbId: mdl
DbLabel: MEDLINE Ultimate
An: 40516695
AccessLevel: 2
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Predictive stability in biopharmaceuticals and vaccines: Perspectives and recommendations towards accelerating patient access.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AU" term="%22Skomski+D%22">Skomski D</searchLink>; Merck & Co., Inc., Analytical R&D, 126 E Lincoln Ave, Rahway, NJ, USA. Electronic address: daniel.skomski@merck.com.<br /><searchLink fieldCode="AU" term="%22Ji+A%22">Ji A</searchLink>; Genentech, Pharmaceutical Development, 1 DNA Way, South San Francisco, CA 94080.<br /><searchLink fieldCode="AU" term="%22Kuzman+D%22">Kuzman D</searchLink>; Novartis Ltd, Biologics Drug Product Development, Technical Research and Development, Kolodvorska 27, 1234 Menges, Slovenia.<br /><searchLink fieldCode="AU" term="%22Clenet+D%22">Clenet D</searchLink>; Sanofi Pasteur, Global Bioprocess Development, Vaccine CMC Development & Supply, 1541 Avenue Marcel Merieux, Marcy-L' Etoile 69280, France.<br /><searchLink fieldCode="AU" term="%22Hieb+A%22">Hieb A</searchLink>; Genentech, Pharmaceutical Development, 1 DNA Way, South San Francisco, CA 94080.<br /><searchLink fieldCode="AU" term="%22Roberts+SW%22">Roberts SW</searchLink>; Novo Nordisk A/S, Regulatory Affairs, Chemistry, Manufacturing and Controls, Søborg, DK.<br /><searchLink fieldCode="AU" term="%22Berry+J%22">Berry J</searchLink>; Eli Lilly and Company, Global Regulatory Affairs, CMC, Lilly Corporate Center, Indianapolis, IN 46285.<br /><searchLink fieldCode="AU" term="%22Lentes+C%22">Lentes C</searchLink>; F. Hoffmann-La Roche Ltd., Pharmaceutical Development & Supplies, Pharmaceutical Technical Development Biologics Europe, Grenzacherstrasse 124, 4070 Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Weusten+J%22">Weusten J</searchLink>; MSD, Center for Mathematical Sciences, Vollenhovermeer 2, 5347 JV, Oss, The Netherlands.<br /><searchLink fieldCode="AU" term="%22MacArthur+K%22">MacArthur K</searchLink>; Pfizer, Inc., Global CMC Vaccines, 66 Hudson Boulevard East, NY, NY 10001, USA.<br /><searchLink fieldCode="AU" term="%22Charles+AS%22">Charles AS</searchLink>; Pfizer, Inc., Analytical Research & Development, 875 Chesterfield Parkway West, Chesterfield, MO 63017, USA.<br /><searchLink fieldCode="AU" term="%22Ahlstrom+B%22">Ahlstrom B</searchLink>; Amgen Inc., Quality, One Amgen Center Drive, Thousand Oaks, CA 91320.<br /><searchLink fieldCode="AU" term="%22Auguste-Bowler+S%22">Auguste-Bowler S</searchLink>; Novo Nordisk A/S, Rare Diseases.<br /><searchLink fieldCode="AU" term="%22Chinn+L%22">Chinn L</searchLink>; Sanofi Pasteur, Regulatory Affairs, Sanofi Pasteur, 1755 Steeles Ave W, North York, Ontario, M2R 3T4, Canada.<br /><searchLink fieldCode="AU" term="%22Boehrer+A%22">Boehrer A</searchLink>; Boehringer Ingelheim Pharma GmbH & Co. KG, Global Development CMC Biologicals, 88397 Biberach/Riss, Germany.<br /><searchLink fieldCode="AU" term="%22Feng+S%22">Feng S</searchLink>; AbbVie Inc., Department of Development Sciences, 2525 Dupont Dr., Irvine, CA, USA.<br /><searchLink fieldCode="AU" term="%22Thompson+C%22">Thompson C</searchLink>; Astra Zeneca, CMC Statistics, Data Science and Modelling, Biopharmaceutical Development, Gaithersburg, MD.<br /><searchLink fieldCode="AU" term="%22Francq+B%22">Francq B</searchLink>; GSK, Technical R&D, 89 rue de l'Institut, 1330 Rixensart, Belgium.<br /><searchLink fieldCode="AU" term="%22Laue+C%22">Laue C</searchLink>; Merck Healthcare KGaA, Analytical Development & Innovation NCE, Frankfurter Str. 250, 64293 Darmstadt, Germany.<br /><searchLink fieldCode="AU" term="%22Bury+ME%22">Bury ME</searchLink>; Novartis Pharma AG, Regulatory Affairs CMC Biologics, CH-4056 Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Rauk+AP%22">Rauk AP</searchLink>; Development Statistics, Eli Lilly and Company, Lilly Corporate Center, 893 Delaware St, Indianapolis, IN 46225, USA.<br /><searchLink fieldCode="AU" term="%22Cui+T%22">Cui T</searchLink>; Johnson & Johnson, Drug Product Development & Delivery, Archimedesweg 30, 2333CN, Leiden, NL.<br /><searchLink fieldCode="AU" term="%22Scholfield+M%22">Scholfield M</searchLink>; Astra Zeneca, Dosage Form Design & Development, BioPharmaceutical Development, BioPharmaceuticals R&D, Gaithersburg, MD 20878, USA.<br /><searchLink fieldCode="AU" term="%22Meleties+M%22">Meleties M</searchLink>; Regeneron Pharmaceuticals, Inc., Formulations Development, 777 Old Saw Mill River Road, Tarrytown, NY, 10591 USA.<br /><searchLink fieldCode="AU" term="%22Kronimus+Y%22">Kronimus Y</searchLink>; Boehringer Ingelheim Pharma GmbH & Co. KG, Global Development CMC Biologicals, 88397 Biberach/Riss, Germany.<br /><searchLink fieldCode="AU" term="%22Jakka+K%22">Jakka K</searchLink>; GSK, Investigator Analytical Development, 1250 S. Collegeville Road, Collegeville, PA 19426-0989, United States.<br /><searchLink fieldCode="AU" term="%22Boncina+M%22">Boncina M</searchLink>; Novartis Ltd, Biologics Drug Product Development, Technical Research and Development, Kolodvorska 27, 1234 Menges, Slovenia.<br /><searchLink fieldCode="AU" term="%22Burgers+P%22">Burgers P</searchLink>; Johnson & Johnson, Clinical Stability Studies.<br /><searchLink fieldCode="AU" term="%22Krug+E%22">Krug E</searchLink>; Eli Lilly and Company, Bioproduct Development, Lilly Corporate Center, 893 Delaware St, Indianapolis, IN 46225, USA.<br /><searchLink fieldCode="AU" term="%22Segarra+E%22">Segarra E</searchLink>; Amgen Inc., Quality, One Amgen Center Drive, Thousand Oaks, CA 91320.<br /><searchLink fieldCode="AU" term="%22Wu+J%22">Wu J</searchLink>; Regeneron Pharmaceuticals, Inc., Formulations Development, 777 Old Saw Mill River Road, Tarrytown, NY, 10591 USA.<br /><searchLink fieldCode="AU" term="%22Kalonia+C%22">Kalonia C</searchLink>; Astra Zeneca, Dosage Form Design & Development, BioPharmaceutical Development, BioPharmaceuticals R&D, Gaithersburg, MD 20878, USA.<br /><searchLink fieldCode="AU" term="%22Lowney+D%22">Lowney D</searchLink>; Johnson & Johnson, Clinical Stability Studies.
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%222985195R%22">Journal of pharmaceutical sciences</searchLink> [J Pharm Sci] 2025 Aug; Vol. 114 (8), pp. 103873. <i>Date of Electronic Publication: </i>2025 Jun 13.
– Name: TypePub
  Label: Publication Type
  Group: TypPub
  Data: Journal Article; Review
– Name: TitleSource
  Label: Journal Info
  Group: Src
  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%22">Elsevier </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>2985195R <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1520-6017 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2200223549%22">00223549 </searchLink><i>NLM ISO Abbreviation: </i>J Pharm Sci <i>Subsets: </i>MEDLINE
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=40516695
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1016/j.xphs.2025.103873
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        StartPage: 103873
    Titles:
      – TitleFull: Predictive stability in biopharmaceuticals and vaccines: Perspectives and recommendations towards accelerating patient access.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Skomski D
      – PersonEntity:
          Name:
            NameFull: Ji A
      – PersonEntity:
          Name:
            NameFull: Kuzman D
      – PersonEntity:
          Name:
            NameFull: Clenet D
      – PersonEntity:
          Name:
            NameFull: Hieb A
      – PersonEntity:
          Name:
            NameFull: Roberts SW
      – PersonEntity:
          Name:
            NameFull: Berry J
      – PersonEntity:
          Name:
            NameFull: Lentes C
      – PersonEntity:
          Name:
            NameFull: Weusten J
      – PersonEntity:
          Name:
            NameFull: MacArthur K
      – PersonEntity:
          Name:
            NameFull: Charles AS
      – PersonEntity:
          Name:
            NameFull: Ahlstrom B
      – PersonEntity:
          Name:
            NameFull: Auguste-Bowler S
      – PersonEntity:
          Name:
            NameFull: Chinn L
      – PersonEntity:
          Name:
            NameFull: Boehrer A
      – PersonEntity:
          Name:
            NameFull: Feng S
      – PersonEntity:
          Name:
            NameFull: Thompson C
      – PersonEntity:
          Name:
            NameFull: Francq B
      – PersonEntity:
          Name:
            NameFull: Laue C
      – PersonEntity:
          Name:
            NameFull: Bury ME
      – PersonEntity:
          Name:
            NameFull: Rauk AP
      – PersonEntity:
          Name:
            NameFull: Cui T
      – PersonEntity:
          Name:
            NameFull: Scholfield M
      – PersonEntity:
          Name:
            NameFull: Meleties M
      – PersonEntity:
          Name:
            NameFull: Kronimus Y
      – PersonEntity:
          Name:
            NameFull: Jakka K
      – PersonEntity:
          Name:
            NameFull: Boncina M
      – PersonEntity:
          Name:
            NameFull: Burgers P
      – PersonEntity:
          Name:
            NameFull: Krug E
      – PersonEntity:
          Name:
            NameFull: Segarra E
      – PersonEntity:
          Name:
            NameFull: Wu J
      – PersonEntity:
          Name:
            NameFull: Kalonia C
      – PersonEntity:
          Name:
            NameFull: Lowney D
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 08
              Text: 2025 Aug
              Type: published
              Y: 2025
          Identifiers:
            – Type: issn-electronic
              Value: 1520-6017
          Numbering:
            – Type: volume
              Value: 114
            – Type: issue
              Value: 8
          Titles:
            – TitleFull: Journal of pharmaceutical sciences
              Type: main
ResultId 1