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Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins

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...

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Autores principales: Krayukhina, Elena, Tsumoto, Kouhei, Uchiyama, Susumu, Fukui, Kiichi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BlackWell Publishing Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4359023/
https://www.ncbi.nlm.nih.gov/pubmed/25256796
http://dx.doi.org/10.1002/jps.24184
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author Krayukhina, Elena
Tsumoto, Kouhei
Uchiyama, Susumu
Fukui, Kiichi
author_facet Krayukhina, Elena
Tsumoto, Kouhei
Uchiyama, Susumu
Fukui, Kiichi
author_sort Krayukhina, Elena
collection PubMed
description 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. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:527–535, 2015
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spelling pubmed-43590232015-03-19 Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins Krayukhina, Elena Tsumoto, Kouhei Uchiyama, Susumu Fukui, Kiichi J Pharm Sci Pharmaceutical Biotechnology 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. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:527–535, 2015 BlackWell Publishing Ltd 2015-02 2014-09-24 /pmc/articles/PMC4359023/ /pubmed/25256796 http://dx.doi.org/10.1002/jps.24184 Text en © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association
spellingShingle Pharmaceutical Biotechnology
Krayukhina, Elena
Tsumoto, Kouhei
Uchiyama, Susumu
Fukui, Kiichi
Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins
title Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins
title_full Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins
title_fullStr Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins
title_full_unstemmed Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins
title_short Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins
title_sort effects of syringe material and silicone oil lubrication on the stability of pharmaceutical proteins
topic Pharmaceutical Biotechnology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4359023/
https://www.ncbi.nlm.nih.gov/pubmed/25256796
http://dx.doi.org/10.1002/jps.24184
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