Evaluation of a novel cyclic olefin polymer container system for cryopreservation of adeno-associated virus

Kraft, Crystal; Glen, Katie E.; Harriman, J.; Thomas, Robert J.; Lyness, Alexander

doi:10.1016/j.jcyt.2020.03.300

Cited by 3 publications

(2 citation statements)

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“…The results showed that AAV recovery was much higher after storage in COP compared with that after storage in glass, indicating the higher tendency of AAV vector to adsorb onto glass surfaces. 20 Other work has revealed that glass and polypropylene adsorb AAV more than polystyrene. 21 Stability studies of rAAV2 Reference Standard Material revealed that storage in both glass and polypropylene containers resulted in a 30%-40% drop in the vector titer.…”

Section: Introductionmentioning

confidence: 99%

Reduction of Recombinant Adeno-Associated Virus Vector Adsorption on Solid Surfaces by Polyionic Hydrophilic Complex Coating

Ramy

Ueda

Nakajima

et al. 2022

Journal of Pharmaceutical Sciences

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Section: Introductionmentioning

confidence: 99%

Reduction of Recombinant Adeno-Associated Virus Vector Adsorption on Solid Surfaces by Polyionic Hydrophilic Complex Coating

Ramy

Ueda

Nakajima

et al. 2022

Journal of Pharmaceutical Sciences

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“…More recently, vials made of cyclic olefin polymers and copolymers (COP and COC) have attracted attention as they have overcome the major drawbacks of glass by showing excellent chemical resistance [ 9 ] and low adsorption [ 7 , 12 , 13 ], while likewise providing a translucent and inert surface [ 7 ]. Moreover, an obvious benefit over glass is the great break resistance of the polymers, which therefore makes them favorable for recent cell and gene therapies as well [ 10 , 14 , 15 , 16 ]. Moreover, an environmental benefit using polymer over glass vials was found [ 17 ].…”

Section: Introductionmentioning

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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The ice age – A review on formulation of Adeno-associated virus therapeutics

Grossen,

Skaripa Koukelli,

van Haasteren

et al. 2023

European Journal of Pharmaceutics and Biopharmaceutics

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Evaluation of a novel cyclic olefin polymer container system for cryopreservation of adeno-associated virus

Cited by 3 publications

References 0 publications

Reduction of Recombinant Adeno-Associated Virus Vector Adsorption on Solid Surfaces by Polyionic Hydrophilic Complex Coating

Reduction of Recombinant Adeno-Associated Virus Vector Adsorption on Solid Surfaces by Polyionic Hydrophilic Complex Coating

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

The ice age – A review on formulation of Adeno-associated virus therapeutics

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