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…
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…
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…
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…
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…
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…
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…
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…
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…
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…