ArticlePharmaceutics2022
Long-Term Stability Prediction for Developability Assessment of Biopharmaceutics Using Advanced Kinetic Modeling.
Article in Pharmaceutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed.
- Nutritional detoxification strategies in aquaculture: bioactive feed additives mitigating oxidative stress and xenobiotic toxicity in fish.Fish physiology and biochemistry · 2026Review
- From marine predator to pharmacology: Conotoxin diversity, discovery, and therapeutic potential.Zoological research · 2026Review
- Article
- Simplified kinetic modeling for predicting the stability of complex biotherapeutics.Scientific reports · 2025Article
- Formulation development of a stable influenza recombinant neuraminidase vaccine candidate.Human vaccines & immunotherapeutics · 2024Article
- Assessing Drug Product Shelf Life Using the Accelerated Stability Assessment Program: A Case Study of a GLPG4399 Capsule Formulation.Pharmaceutics · 2024Article
- Improving Downstream Process Related Manufacturability Based on Protein Engineering-A Feasibility Study.Engineering in life sciences · 2024Article
- Article
- InvestigatingHeliyon · 2024Article
- Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes.The AAPS journal · 2024Article
- A thermodynamic investigation into protein-excipient interactions involving different grades of polysorbate 20 and 80.Journal of thermal analysis and calorimetry · 2024Article
- Nanophytosome formulation of β-1,3-glucan andMethodsX · 2023Article
- A universal tool for stability predictions of biotherapeutics, vaccines and in vitro diagnostic products.Scientific reports · 2023Article
- Modeling study of long-term stability of the monoclonal antibody infliximab and biosimilars using liquid-chromatography-tandem mass spectrometry and size-exclusion chromatography-multi-angle light scattering.Analytical and bioanalytical chemistry · 2023Article
- Review
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Authors and funding
3 authors.
Funding
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Abstract
A crucial aspect of pharmaceutical development is the demonstration of long-term stability of the drug product. Biopharmaceuticals, such as proteins or peptides in liquid formulation, are typically administered via parental routes and should be stable over the shelf life, which generally includes a storing period (e.g., two years at 5 °C) and optionally an in-use period (e.g., 28 days at 30 °C). Herein, we present a case study where chemical degradation of SAR441255, a therapeutic peptide, in different formulations in combination with primary packaging materials was analyzed under accelerated conditions to derive long-term stability predictions for the recommended storing conditions (two years at 5 °C plus 28 days at 30 °C) using advanced kinetic modeling. These predictions served as a crucial decision parameter for the entry into clinical development. Comparison with analytical data measured under long-term conditions during the subsequent development phase demonstrated a high prediction accuracy. These predictions provided stability insights within weeks that would otherwise take years using measurements under long-term stability conditions only. To our knowledge, such in silico studies on stability predictions of a therapeutic peptide using accelerated chemical degradation data and advanced kinetic modeling with comparisons to subsequently measured real-life long-term stability data have not been described in literature before.
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