Bevacizumab for Intravitreal Injection: Impact of Sub-Visible Particles on the Shelf-Life of Repackaged Bevacizumab

Crul, Mirjam; Zandvliet, Anthe S.; Moes, Jan Reindert; Veenbaas, Tjitske; Smeets, Oscar

doi:10.1089/jop.2019.0042

Cited by 9 publications

(6 citation statements)

References 20 publications

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“…Fourthly, 14% of the pharmacists do not perform visual examination for particles of the prepared mAbs before administration. This is a major risk, since visible particles may lead to safety issues, including immune reactions [2–5,15,17,27] . This can easily be avoided as it does not take much time to realise visual examination.…”

Section: Discussionmentioning

confidence: 99%

“…This is a major risk, since visible particles may lead to safety issues, including immune reactions. [2][3][4][5]15,17,27] This can easily be avoided as it does not take much time to realise visual examination. Finally, there is a lack of training of health-care staff on the proper handling of mAbs.…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, Crul et al studied the impact of sub-visible particles on the shelf-life of repackaged bevacizumab. These authors concluded that the number of particles increased due to the repackaging process, but no considerable increase was observed during storage for up to 37 days [17] …”

Section: Introductionmentioning

confidence: 99%

“…These authors concluded that the number of particles increased due to the repackaging process, but no considerable increase was observed during storage for up to 37 days. [17] In recent years, several studies have been published on the use of a closed system transfer device (CSTD) for biologic products and focused on the benefits and shortcomings of these devices. [18][19][20][21] Petoskey et al indicated that CSTDs may introduce sub-visible particles into an antibody-drug conjugate (ADC) formulation.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of post-production handling practices of monoclonal antibodies throughout the world

Fayek

Soleyman

Jiskoot

et al. 2021

European Journal of Oncology Pharmacy

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Introduction: This survey aimed to create a snapshot of the post-production handling of monoclonal antibodies in daily practice in health-care facilities in several parts of the world. Methods: A worldwide web-based survey was distributed among pharmacists between November and December 2020. The questions were categorized in sections related to storage conditions, reconstitution practices including the use of medical devices, administration practices, transportation, visual examination and shelf-life of mAbs, education of health-care professionals, and patient's home-administration. Results: A total of 247 responders from 37 countries around the world participated in the survey. Hospital pharmacists were the largest group of respondents (92%). Most of the respondents (92%) reported that they store the mAbs at 2 to 8°C and 71% protect the prepared ready-to-administer mAbs from light by secondary packaging. The participants used spikes (38%), closed system transfer devices (CSTDs) (12%), and needles (22%) or a combination of these (28%) as a medical device, and 89% perform the reconstitution practices manually, versus 4% by semi-automatic pump system, 1% by robot, and 5% by a combination of these reconstitution methods. The respondents reported that in their institution, after compounding mAbs are transported via a logistic employee on foot at ambient temperature (59%) or in a cool-box (20%), or via the tube system (7%). More than half (64%) do not have written guidelines for transportation, but 86% perform a visual examination for particles of prepared mAbs before administration. Furthermore, 52% of the responders answered that nurses as well as pharmacists and pharmacy assistants receive staff training on the potential risks of mAb handling. Conclusion: There is a high level of variability in daily practices of mAb handling in pharmacies worldwide.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Evaluation of post-production handling practices of monoclonal antibodies throughout the world

Fayek

Soleyman

Jiskoot

et al. 2021

European Journal of Oncology Pharmacy

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“…requirements. 11,12 Nevertheless, the high particle loads in repackaged bevacizumab are primarily tied to the use of siliconized transfer syringes for the repackaging. 10,13 Over the past few years, the Food and Drug Administration (FDA) has taken steps to define 14 and enforce 15 particle-related regulations in the 503B outsourcing facility industry.…”

mentioning

confidence: 99%