A discussion of silver’s cytotoxicity with respect to the biological evaluation of a wound dressing

A discussion of silver’s cytotoxicity with respect to the biological evaluation of a wound dressing

Client An international manufacturer of wound care products. Background According to the results of an in vitro cytotoxicity assay, conducted in accordance with ISO 10993-5 guidelines, an extract of the client’s silver-containing wound dressing product demonstrated evidence of toxicity to mouse fibroblast cells. Project goals…

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Biological risk assessment of a new size of medical device

Biological risk assessment of a new size of medical device

Client An international manufacturer of wound care products. Background The client, who markets a wound dressing with existing EU and US FDA approval for long-term (>30 days), has since manufactured a larger-sized, but otherwise identical, variant of this product. Project goals According to ISO 10993-1…

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A consumer health risk assessment of e-liquid containers

A consumer health risk assessment of e-liquid containers

Client A US manufacturer and supplier of container closure systems designed for e-liquids. Background In order to inform e-liquid manufacturers of any hazardous chemicals that may potentially leach from the containers into their e-liquid formulations for Premarket Tobacco Product Application (PMTA) submissions to the US…

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Evaluation of the endocrine-disrupting potential of two plant protection products

Evaluation of the endocrine-disrupting potential of two plant protection products

Client A regulatory and toxicology consultancy. Background Under the recent amendment to the plant protection products regulation (Regulation (EU) 2018/605), information on the potential endocrine-disrupting (ED) properties of such products must be collated and evaluated. Project goals To evaluate the ED properties of two plant…

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Evaluation of the endocrine-disrupting potential of two biocidal products

Evaluation of the endocrine-disrupting potential of two biocidal products

Client A regulatory consultancy, specialising in biocidal products. Background Under the recent amendment to the biocidal products regulation (Regulation (EU) 2017/2100), information on the potential endocrine-disrupting (ED) properties of such products must be collated and evaluated. Project goals To evaluate the ED properties of two…

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Toxicity assessment of CBD as an active pharmaceutical ingredient (API) in an inhaler device

Toxicity assessment of CBD as an active pharmaceutical ingredient (API) in an inhaler device

Client A pharmaceutical company. Background The client is interested in using CBD (cannabidiol), the major non-psychoactive component of cannabis, in a breath-operated medical inhaler device. CBD has been associated with a range of therapeutic benefits, but the current knowledge about its toxicity is something that…

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Toxicity review of CBD for use as a novel ingredient in e-liquids

Toxicity review of CBD for use as a novel ingredient in e-liquids

Client A manufacturer of e-cigarettes. Background The client is interested in introducing CBD (cannabidiol), the major non-psychoactive component of cannabis, as an ingredient to its e-liquids. The e-liquids are intended to be used in vaping products, which could potentially expose the lungs of consumers to…

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ISO 10993 risk assessment of ester extractables from a medical device

ISO 10993 risk assessment of ester extractables from a medical device

Client An analytical lab working on the behalf of a medical devices manufacturer. Background Extraction studies on a device used to transfer injectable medium identified several esters that could, as a worst case, leach over time into the contained fluid, and subsequently be injected into…

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Acceptable intake for an impurity in a new anticancer drug

Acceptable intake for an impurity in a new anticancer drug

Client A pharmaceutical company. Background A possible impurity was identified in the development of a new anticancer drug. Project goals Bibra was asked to conduct Leadscope analyses on this impurity to assess its genotoxic/mutagenic potential and to subsequently classify it in line with ICH guideline…

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Health risk assessment of a nicotine salt

Health risk assessment of a nicotine salt

Background Nicotine can be added to e-liquids either in its basic form or as a nicotine salt. Bibra was approached by a client interested in assessing the use of a particular salt as a source of nicotine in one of its e-liquid products. Client A…

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