ArticleJournal of pharmaceutical sciences2015
Effects of syringe material and silicone oil lubrication on the stability of pharmaceutical proteins.
Article in Journal of pharmaceutical sciences, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.
What it found
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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.
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Who cites it
31 citing papers in PubMed.
- An Orthogonal Framework for Higher-Order Structural and In Vitro Functional Comparability of Chemically Synthesized Liraglutide Relative to an rDNA-Origin Reference Product.Pharmaceutical research · 2026Article
- Bio-Inspired, Zwitterionic Copolymers with Amphiphilic Character.Macromolecular rapid communications · 2026Article
- Fluorescence Quantification of Silicone Oil Release upon Contact with Liquid Therapeutic Formulations.Methods and protocols · 2026Article
- Guiding syringe selection for intravitreal injections: injectability and stability analysis of compounded pegcetacoplan (SYFOVRE) and the broader implications for high-viscosity ophthalmic therapies.International journal of retina and vitreous · 2026Article
- Machine Learning-Enabled Image Comparability Assessment for Flow Imaging Microscopy Across Platforms.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Incidence and Clinical Course of Intraocular Inflammation Following Pharmacy-Compounded Intravitreal Aflibercept 8mg for Neovascular AMD: A Real-World Cohort Study.Clinical ophthalmology (Auckland, N.Z.) · 2026Article
- Intraocular inflammation following intravitreal injections of anti-vascular endothelial growth factor drugs.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025Observational
- Highly variable aggregation and glycosylation profiles and their roles in immunogenicity to protein-based therapeutics.Journal of pharmaceutical sciences · 2025Review
- A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic.Pharmaceutical research · 2024Article
- Comparative Study of Sorption Phenomena Between Three Medications and Syringes Made of Cyclic Olefin Copolymer or Polypropylene.Pharmaceutical research · 2024Article
- Convolutional Neural Networks Enable Highly Accurate and Automated Subvisible Particulate Classification of Biopharmaceuticals.Pharmaceutical research · 2023Article
- Steps toward nebulization in-use studies to understand the stability of new biological entities.Drug discovery today · 2023Review
- Alternative Excipients for Protein Stabilization in Protein Therapeutics: Overcoming the Limitations of Polysorbates.Pharmaceutics · 2022Review
- Ocular inflammation after agitation of siliconized and silicone oil-free syringes: a randomized, double-blind, controlled clinical trial.International journal of retina and vitreous · 2022Article
- Differences in the incidence of aflibercept-related sterile endophthalmitis according to types of disposable syringes used.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2022Article
- A Silicone Oil-Free Syringe Tailored for Intravitreal Injection of Biologics.Frontiers in ophthalmology · 2022Article
- Assessment of Therapeutic Antibody Developability by Combinations of In Vitro and In Silico Methods.Methods in molecular biology (Clifton, N.J.) · 2022Article
- Catastrophic Embolism Following Cosmetic Injection of Autologous Fat: Are Silicone-Treated Syringes the Only Suspects on the Crime Scene?Frontiers in surgery · 2022Article
- Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review.International journal of retina and vitreous · 2021Review
- Machine learning and statistical analyses for extracting and characterizing "fingerprints" of antibody aggregation at container interfaces from flow microscopy images.Biotechnology and bioengineering · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Currently, polymer-based prefillable syringes are being promoted to the pharmaceutical market because they provide an increased break resistance relative to traditionally used glass syringes. Despite this significant advantage, the possibility that barrel material can affect the oligomeric state of the protein drug exists. The present study was designed to compare the effect of different syringe materials and silicone oil lubrication on the protein aggregation. The stability of a recombinant fusion protein, abatacept (Orencia), and a fully human recombinant immunoglobulin G1, adalimumab (Humira), was assessed in silicone oil-free (SOF) and silicone oil-lubricated 1-mL glass syringes and polymer-based syringes in accelerated stress study. Samples were subjected to agitation stress, and soluble aggregate levels were evaluated by size-exclusion chromatography and verified with analytical ultracentrifugation. In accordance with current regulatory expectations, the amounts of subvisible particles resulting from agitation stress were estimated using resonant mass measurement and dynamic flow-imaging analyses. The amount of aggregated protein and particle counts were similar between unlubricated polymer-based and glass syringes. The most significant protein loss was observed for lubricated glass syringes. These results suggest that newly developed SOF polymer-based syringes are capable of providing biopharmaceuticals with enhanced physical stability upon shipping and handling.
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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.