ReviewAdvanced drug delivery reviews2015
Stabilization of proteins in solid form.
Review in Advanced drug delivery reviews, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed.
- Pharmacokinetics and Pharmacodynamics of Rusfertide, a Hepcidin Mimetic, Following Subcutaneous Administration of a Lyophilized Powder Formulation in Healthy Volunteers.Drugs in R&D · 2024Trial
- Optimization of Sugar-Derivatives Mixtures for Stabilizing Polyclonal Immunoglobulin G in Spray-Dried Inhalable Powders During Processing and Long-Term Storage.Pharmaceutics · 2026Article
- A Portable Fluorometer for the Detection of Glyphosate.Biosensors · 2026Article
- The Detrimental Effects of Crystalline Excipients: How They Jeopardize the Long-Term Stability of Freeze-Dried Polypeptide Formulations.Pharmaceutics · 2025Article
- Phage therapeutic delivery methods and clinical trials for combating clinically relevant pathogens.Therapeutic delivery · 2025Review
- Regulatory Guidelines for the Analysis of Therapeutic Peptides and Proteins.Journal of peptide science : an official publication of the European Peptide Society · 2025Review
- Formulation development and feasibility of AAV5 as a lyophilized drug product.Journal of pharmaceutical sciences · 2025Article
- The Role of Phase Separation and Local Mobility in the Stabilization of a Lyophilized IgG2 Formulation.AAPS PharmSciTech · 2024Article
- Dynamical Transition in Dehydrated Proteins.The journal of physical chemistry letters · 2024Article
- Predicting the Stability of Lyophilized Human Serum Albumin Formulations Containing Sucrose and Trehalose Using Solid-State NMR Spectroscopy: Effect of Storage Temperature onThe AAPS journal · 2024Article
- Effect of Buffer Salts on Physical Stability of Lyophilized and Spray-Dried Protein Formulations Containing Bovine Serum Albumin and Trehalose.Pharmaceutical research · 2023Article
- Positron Annihilation Lifetime Spectroscopy as a Special Technique for the Solid-State Characterization of Pharmaceutical Excipients, Drug Delivery Systems, and Medical Devices-A Systematic Review.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Enhanced Stability of Vegetal Diamine Oxidase with Trehalose and Sucrose as Cryoprotectants: Mechanistic Insights.Molecules (Basel, Switzerland) · 2023Article
- Protein Stability: Enhancement and Measurement.Methods in molecular biology (Clifton, N.J.) · 2023Article
- Radio Frequency - Assisted Ultrasonic Spray Freeze Drying for Pharmaceutical Protein Solids.Journal of pharmaceutical sciences · 2023Article
- Stable Dried Catalase Particles Prepared by Electrospraying.Nanomaterials (Basel, Switzerland) · 2022Article
- Enhancing the Stabilization Potential of Lyophilization for Extracellular Vesicles.Advanced healthcare materials · 2022Article
- The Effect of High Protein Powder Structure on Hydration, Glass Transition, Water Sorption, and Thermomechanical Properties.Foods (Basel, Switzerland) · 2022Article
- An optimized Factor H-Fc fusion protein against multidrug-resistantFrontiers in immunology · 2022Article
- Calorimetric Investigation of the Relaxation Phenomena in Amorphous Lyophilized Solids.Pharmaceutics · 2021Review
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Authors and funding
3 authors.
Funding
Abstract
Immunogenicity of aggregated or otherwise degraded protein delivered from depots or other biopharmaceutical products is an increasing concern, and the ability to deliver stable, active protein is of central importance. We review characterization approaches for solid protein dosage forms with respect to metrics that are intended to be predictive of protein stability against aggregation and other degradation processes. Each of these approaches is ultimately motivated by hypothetical connections between protein stability and the material property being measured. We critically evaluate correlations between these properties and stability outcomes, and use these evaluations to revise the currently standing hypotheses. Based on this we provide simple physical principles that are necessary (and possibly sufficient) for generating solid delivery vehicles with stable protein loads. Essentially, proteins should be strongly coupled (typically through H-bonds) to the bulk regions of a phase-homogeneous matrix with suppressed β relaxation. We also provide a framework for reliable characterization of solid protein forms with respect to stability.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.