Effect of inline filtration on ViaSpan cold-storage solution

Mueller, Bradford J.; Guessford, Stacey A.; Chen, Tracy T.; Karczmarcyk, Rosalie M.; Schreiber, Mark A.; Ycas, J.; Gorko, Mary Ann; Repta, A.J.

doi:10.1093/ajhp/55.3.266

Cited by 4 publications

(2 citation statements)

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“…In retrospect, despite a recommendation to filter UW solution with a 40-pm filter [14], it is uncertain that this would have been completely effective for our monkeys because the preponderance of particles we observed were under 40 pm. The recommended filter was found to be 99% effective only for particles of 25 pm and larger, with 44% of 5-10-pm and 29% of 10-25-pm particles passing the filter [15]. In contrast, the use of 0.2-pm filtration as performed by Walcher et al.…”

Section: Discussionmentioning

confidence: 96%

Particle-induced circulatory disturbances in transplanted rhesus macaque kidneys

Hubbard

Hutchings

Eckhoff

et al. 2003

Transplant International

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We have demonstrated the presence of crystalline particles in University of Wisconsin (UW) solution used to perfuse rhesus monkey kidney transplants. These particles were visible in obstructed blood vessels and associated with immediate graft thrombosis and necrosis. This occurred in 25.7% of kidneys perfused with UW solution and transplanted into young, unsensitized recipients. Two molecular species of crystals were defined by mass spectrometry. The particle size ranged from 3 to greater than 100 microm, with a preponderance of particles less than 25 microm in diameter. Such particles are not removed by 40-microm filtration, but can be removed by centrifugation. With extensive use of UW solution for organ storage, the potential for particle-induced damage in small vessels in both experimental and human transplants needs to be carefully scrutinized.

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Section: Discussionmentioning

confidence: 96%

Particle-induced circulatory disturbances in transplanted rhesus macaque kidneys

Hubbard

Hutchings

Eckhoff

et al. 2003

Transplant International

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“…Precipitation of small quantities of calcium, magnesium, and zinc fatty acid salts led to the formation of visible and sub visible particulates in a solution for storage and flushing of organs for transplantation (ViaSpan, DuPont Merck Pharmaceutical) [46]. The extent of the subsequent precipitate formation is dependent on the solution pH.…”

Section: Table 104 Elemental Analysis Of Flakes Found In a Solution mentioning

confidence: 99%

Particulate Matter

2012

Sources of Contamination in Medicinal Products and Medical Devices

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Drug Development Considerations for Additives to Organ Preservation Solutions

O’Brien Laramy,

Robinson,

Venkatramani

et al. 2024

Transplantation

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The addition of a novel therapeutic agent to an organ preservation solution has the potential to address unmet needs in organ transplantation and enhance outcomes for transplant recipients. However, the development expectations for novel therapeutic agents in this context are unclear because of limited precedence and published regulatory guidance documents. To address these gaps, we have articulated a drug development strategy that leverages expectations for parenteral drug products administered via more conventional routes (eg, intravenous) and provided considerations for when deviations may be justified. We have supplemented this strategy with a comparison to available regulatory guidance from the US Food and Drug Administration to highlight potential areas for further clarification. The strategy articulated here is based on Genentech’s internal experience for a program intended for use in kidney transplantation.

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Effect of inline filtration on ViaSpan cold-storage solution

Cited by 4 publications

References 0 publications

Particle-induced circulatory disturbances in transplanted rhesus macaque kidneys

Particle-induced circulatory disturbances in transplanted rhesus macaque kidneys

Particulate Matter

Drug Development Considerations for Additives to Organ Preservation Solutions

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