Predictive Stability in Biopharmaceuticals and Vaccines: Perspectives and Recommendations Towards Accelerating Patient Access.

Journal: Journal of pharmaceutical sciences
Published Date: Jun 12, 2025

Abstract

The perspective review discusses predictive stability computational modeling and scientific risk-based approaches to prospectively assess long-term stability and shelf-life of biotherapeutics and vaccines. New regulatory approaches are considered in the context of evolving industry guidelines which are expected to lead to increased usage in clinical trials and market applications. Case studies for many critical quality attributes are broadly covered. Model methodologies, complexities, and mitigations, as well as emerging technologies, are also explained. Outputs of an industry-wide survey elucidate how biopharmaceutical companies are navigating this changing environment. Altogether, it is suggested that predictive stability holds promise for accelerating patient access to new medicines by overcoming stability-related bottlenecks while further enhancing scientific understanding and product robustness.

Authors

  • Daniel Skomski
    MRL, Merck & Co., Inc., 126 E. Lincoln Avenue, Rahway, New Jersey 07065. Electronic address: daniel.skomski@merck.com.
  • Andrea Ji
    Genentech, Pharmaceutical Development, 1 DNA Way, South San Francisco, CA 94080.
  • Drago Kuzman
    Novartis Ltd, Biologics Drug Product Development, Technical Research and Development, Kolodvorska 27, 1234 Menges, Slovenia.
  • Didier Clénet
    Vaccine CMC Development & Supply, Sanofi, Marcy-L' Etoile, France.
  • Aaron Hieb
    Genentech, Pharmaceutical Development, 1 DNA Way, South San Francisco, CA 94080.
  • Scott W Roberts
    Novo Nordisk A/S, Regulatory Affairs, Chemistry, Manufacturing and Controls, Søborg, DK.
  • Joe Berry
    Eli Lilly and Company, Global Regulatory Affairs, CMC, Lilly Corporate Center, Indianapolis, IN 46285.
  • Christopher Lentes
    F. Hoffmann-La Roche Ltd., Pharmaceutical Development & Supplies, Pharmaceutical Technical Development Biologics Europe, Grenzacherstrasse 124, 4070 Basel, Switzerland.
  • Jos Weusten
    MSD, Center for Mathematical Sciences, Vollenhovermeer 2, 5347 JV, Oss, The Netherlands.
  • Kirsten MacArthur
    Pfizer, Inc., Global CMC Vaccines, 66 Hudson Boulevard East, New York, NY 10001, USA.
  • Amy St Charles
    Pfizer, Inc., Analytical Research & Development, 875 Chesterfield Parkway West, Chesterfield, MO 63017, USA.
  • Ben Ahlstrom
    Amgen Inc., Quality, One Amgen Center Drive, Thousand Oaks, CA 91320.
  • Sandra Auguste-Bowler
    Novo Nordisk A/S, Rare Diseases.
  • Leanne Chinn
    Sanofi Pasteur, Regulatory Affairs, Sanofi Pasteur, 1755 Steeles Ave W, North York, Ontario, M2R 3T4, Canada.
  • Armin Boehrer
    Boehringer Ingelheim Pharma GmbH & Co. KG, Global Development CMC Biologicals, 88397 Biberach/Riss, Germany.
  • Shaoxin Feng
    AbbVie Inc., Department of Development Sciences, 2525 Dupont Dr., Irvine, CA, USA.
  • Chris Thompson
    Astra Zeneca, CMC Statistics, Data Science and Modelling, Biopharmaceutical Development, Gaithersburg, Maryland.
  • Bernard Francq
    GSK, Technical R&D, 89 rue de l'Institut, 1330 Rixensart, Belgium.
  • Christian Laue
    Merck Healthcare KGaA, Analytical Development & Innovation NCE, Frankfurter Str. 250, 64293 Darmstadt, Germany.
  • Marie-Eve Bury
    Novartis Pharma AG, Regulatory Affairs CMC Biologics, CH-4056 Basel, Switzerland.
  • Adam Palmer Rauk
    Development Statistics, Eli Lilly and Company, Lilly Corporate Center, 893 Delaware St, Indianapolis, IN 46225, USA.
  • Thijs Cui
    Johnson & Johnson, Drug Product Development & Delivery, Archimedesweg 30, 2333CN, Leiden, NL.
  • Matthew Scholfield
    Astra Zeneca, Dosage Form Design & Development, BioPharmaceutical Development, BioPharmaceuticals R&D, Gaithersburg, MD 20878, USA.
  • Michael Meleties
    Regeneron Pharmaceuticals, Inc., Formulations Development, 777 Old Saw Mill River Road, Tarrytown, New York, 10591 USA.
  • Yannick Kronimus
    Boehringer Ingelheim Pharma GmbH & Co. KG, Global Development CMC Biologicals, 88397 Biberach/Riss, Germany.
  • Kavitha Jakka
    GSK, Investigator Analytical Development, 1250 S. Collegeville Road, Collegeville, Pennsylvania 19426-0989, United States.
  • Matjaz Boncina
    Novartis Ltd, Biologics Drug Product Development, Technical Research and Development, Kolodvorska 27, 1234 Menges, Slovenia.
  • Pepijn Burgers
    Johnson & Johnson, Clinical Stability Studies.
  • Elisabeth Krug
    Eli Lilly and Company, Bioproduct Development, Lilly Corporate Center, 893 Delaware St, Indianapolis, IN 46225, USA.
  • Edgardo Segarra
    Amgen Inc., Quality, One Amgen Center Drive, Thousand Oaks, CA 91320.
  • Jiewei Wu
    Department of Electrical and Electronic Engineering, 255310Southern University of Science and Technology, Shenzhen, China.
  • Cavan Kalonia
    Dosage Form Design and Development, BioPharmaceuticals Development, R&D, AstraZeneca, Gaithersburg, MD, USA.
  • Declan Lowney
    Johnson & Johnson, Clinical Stability Studies.

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