Control of Protein Adsorption to Cyclo Olefin Polymer by the Hofmeister Effect

Fujita, Risako; Nagatoishi, Satoru; Adachi, Souichi; Nishioka, Hiroya; Ninomiya, Hidetaka; Kaya, Takatoshi; Takai, Madoka; Arakawa, Tsutomu; Tsumoto, Kouhei

doi:10.1016/j.xphs.2018.12.023

Cited by 7 publications

(2 citation statements)

References 26 publications

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“…Nevertheless, in general we observe low cumulative particle amounts for both mAbs after storage for 3 months even at elevated temperatures (i.e., 25 °C and 40 °C). More recently, it has been reported that protein adsorption to cyclic olefin polymer is scarcely observed [ 12 , 13 , 40 , 41 ] and if so, it is mainly caused by the hydrophobic effect [ 42 ]. We assume that interaction of LMU2 with the hydrophobic surface of COP is the driving force for the increased subvisible particle counts after lyophilization since the mAb exhibits high hydrophobicity.…”

Section: Discussionmentioning

confidence: 99%

Minimizing Oxidation of Freeze-Dried Monoclonal Antibodies in Polymeric Vials Using a Smart Packaging Approach

Härdter

Menzen²,

Winter

2021

Pharmaceutics

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Primary containers made of cyclic olefin polymer (COP) have recently gained attention since they may overcome several risks and shortcomings of glass containers as they exhibit a high break resistance, biocompatibility, and homogeneous heat transfer during lyophilization. On the downside, COP is more permeable for gases, which can lead to an ingress of oxygen into the container over time. Since oxidation is an important degradation pathway for monoclonal antibodies (mAbs), the continuous migration of oxygen into drug product containers should be avoided overall. To date, no long-term stability studies regarding lyophilizates in polymer vials have been published, potentially because of the unbearable gas permeability. In this study, we demonstrate that after lyophilization in COP vials and storage of these vials in aluminum pouches together with combined oxygen and moisture absorbers (“smart packaging”), oxidation of two lyophilized therapeutic antibodies was as low as in glass vials due to the deoxygenated environment in the pouch. Nevertheless, active removal of oxygen from the primary container below the initial level over time during storage in such “smart” secondary packaging was not achieved. Furthermore, residual moisture was controlled. Overall, the smart packaging reveals a promising approach for long-term stability of biopharmaceuticals; in addition to COP’s known benefits, stable, low oxygen and moisture levels as well as the protection from light and cushioning against mechanical shock by the secondary packaging preserve the sensitive products very well.

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Section: Discussionmentioning

confidence: 99%

Minimizing Oxidation of Freeze-Dried Monoclonal Antibodies in Polymeric Vials Using a Smart Packaging Approach

Härdter

Menzen²,

Winter

2021

Pharmaceutics

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“…[20][21][22] SWCNTs with excellent mechanical properties and electrical conductivity have a higher aspect ratio of length to diameter and specific surface area than multiwalled CNTs. [20] Although adding SWCNTs into COPs can improve the mechanical properties and electrical properties, [21,22] achieving a good SWCNT dispersion in COPs is challenging because COPs have hydrophobic chemical structures, [23] and SWCNTs strongly aggregate due to their high specific area.…”

Section: Introductionmentioning

confidence: 99%

A modified blister mixing element for generating extensional flow in a twin‐screw extruder: Process characterization and dispersion state of carbon nanotubes in cyclo‐olefin polymer

Matsumoto

Tanaka

2022

Polymer Engineering & Sci

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This study aimed to improve the dispersion state of single-walled carbon nanotubes (SWCNTs) in a cyclo-olefin polymer (COP) matrix by introducing extensional flow during the compounding through a twin-screw extruder (TSE). A modified mixing element with multiple holes, called a fixed blister disc (XBD), was developed. To describe the mixing performance of XBD, the flow state was characterized via numerical simulation and acquisition of process data such as pressure drop (ΔP) at XBD and specific mechanical energy (SME), while the operational conditions of TSE were varied. The dispersion state of SWCNTs was evaluated from the viewpoint of the melt viscoelastic property, surface resistivity of extruded samples and mechanical properties of injection molded samples. Furthermore, the dispersion morphology was observed via optical microscopy and scanning electron microscopy. As a result, the mixing performance of XBD was improved by increasing the ratio of throughputs Q to screw speed N s (Q/N s ) since ΔP, which is related to extensional stress, was increased. However, the trade-off relationship between ΔP and SME was confirmed versus Q/N s . Although the dispersion state at the submicron level was markedly improved with higher SME inputs, higher ΔP reduced the largest agglomerate size and improved dispersion uniformity. Consequently, the mechanical properties were improved significantly.

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Prefilled dual chamber devices (DCDs) – Promising high-quality and convenient drug delivery system

Ingle

Fang

2021

International Journal of Pharmaceutics

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Control of Protein Adsorption to Cyclo Olefin Polymer by the Hofmeister Effect

Cited by 7 publications

References 26 publications

Minimizing Oxidation of Freeze-Dried Monoclonal Antibodies in Polymeric Vials Using a Smart Packaging Approach

Minimizing Oxidation of Freeze-Dried Monoclonal Antibodies in Polymeric Vials Using a Smart Packaging Approach

A modified blister mixing element for generating extensional flow in a twin‐screw extruder: Process characterization and dispersion state of carbon nanotubes in cyclo‐olefin polymer

Prefilled dual chamber devices (DCDs) – Promising high-quality and convenient drug delivery system

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