ArticlePharmaceutical research2026
Effects of Siliconization Techniques, Headspace, Mechanical and Thermal Stress on Particle Generation in an Antibody Formulation.
Article in Pharmaceutical research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
objectivePre-filled syringes (PFSs) have become a preferred delivery system for biotherapeutics due to their convenience, accuracy, and cost-effectiveness. Silicone oil (SO) is commonly used as a lubricant in PFSs; however, its leaching can trigger immunogenicity and raise clinical and regulatory concerns. This study evaluates the impact of syringe design and handling parameters on particle formation and aggregation of a model therapeutic antibody in SO-lubricated PFSs.
methodsThe study systematically evaluated multiple factors influencing protein stability in prefilled syringes, including siliconization technique (standard sprayed-on [Stdr] vs. cross-linked [Alba®]), headspace volume (low vs. high), and applied stress conditions (slow freeze-thaw cycles and end-over-end agitation). The antibody formulation stability was assessed to determine the combined effects of these parameters on subvisible particle generation and aggregation. Comprehensive analytical characterization was performed using light obscuration (LO), micro flow imaging, size-exclusion chromatography (SEC), and analytical ultracentrifugation (AUC).
resultSyringes with standard sprayed-on siliconization and larger headspace volumes exhibited substantially higher subvisible particle concentrations and aggregate formation, especially under slow freeze-thaw and high-temperature end-over-end stress conditions. In contrast, syringes with cross-linked siliconization (Alba®) showed markedly reduced silicone oil particle shedding and improved protein stability across all tested stress environments. Collectively, these findings highlight that the siliconization method, headspace volume, and stress conditions act synergistically to influence aggregate formation and silicone oil particle release following fill-finish operations.
conclusionOptimizing syringe design and handling parameters can significantly reduce silicone oil induced particle formation and protein aggregation, thereby improving formulation stability.
Indexed as
Identifiers
42754776What OpenQuestion holds
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.