ArticleScientific reports2023
A universal tool for stability predictions of biotherapeutics, vaccines and in vitro diagnostic products.
Article in Scientific reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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Who cites it
17 citing papers in PubMed.
- Novel non-aqueous rotavirus vaccine: Formulated for thermostability and easy administration.Human vaccines & immunotherapeutics · 2026Article
- Improving the Quality of Lyophilized Animal Vaccines: A Review of Optimization Strategies for Freeze-Drying Processes.Veterinary sciences · 2026Review
- Predictive Stability of Aggregation in Glycoconjugate Vaccines Using Advanced Kinetics Modeling and High-Throughput Screening.Pharmaceutics · 2026Article
- Formulation Matters: The Overlooked Engine of Stability and Success in Antibody-Drug Conjugates.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Inactivated Enterovirus 71 Particle Aggregation Stability: Dynamic Light Scattering Analysis and Stabilizer Identification.Vaccines · 2025Article
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- Assessing the Performance and Lifetime of Cellulose Nitrate Lacquer on Silver.Materials (Basel, Switzerland) · 2025Article
- Fast-Tracking Vaccine Manufacturing: CEPI's Rapid Response Framework for the 100 Days Mission.Vaccines · 2025Article
- Simplified kinetic modeling for predicting the stability of complex biotherapeutics.Scientific reports · 2025Article
- Artificial Intelligence and Internet of Things Integration in Pharmaceutical Manufacturing: A Smart Synergy.Pharmaceutics · 2025Review
- Rationalizing mAb Candidate Screening Using a Single Holistic Developability Parameter.Molecular pharmaceutics · 2025Article
- Article
- Formulation development of a stable influenza recombinant neuraminidase vaccine candidate.Human vaccines & immunotherapeutics · 2024Article
- Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes.The AAPS journal · 2024Article
- Fluorescence-Based Protein Stability Monitoring-A Review.International journal of molecular sciences · 2024Review
- Accelerated Stability Studies: A Frequentist-Bayesian Hybrid Simulation Approach Implemented in the AccelStab R Package.Pharmaceutical statisticsArticle
Corrections and comments
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Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
It is of particular interest for biopharmaceutical companies developing and distributing fragile biomolecules to warrant the stability and activity of their products during long-term storage and shipment. In accordance with quality by design principles, advanced kinetic modeling (AKM) has been successfully used to predict long-term product shelf-life and relies on data from short-term accelerated stability studies that are used to generate Arrhenius-based kinetic models that can, in turn, be exploited for stability forecasts. The AKM methodology was evaluated through a cross-company perspective on stability modeling for key stability indicating attributes of different types of biotherapeutics, vaccines and biomolecules combined in in vitro diagnostic kits. It is demonstrated that stability predictions up to 3 years for products maintained under recommended storage conditions (2-8 °C) or for products that have experienced temperature excursions outside the cold-chain show excellent agreement with experimental real-time data, thus confirming AKM as a universal and reliable tool for stability predictions for a wide range of product types.
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