Derivation of an intravenous PDE for a common leachable
Chemicals that leach into drug products from processing or manufacturing equipment, drug delivery systems and/or packaging may pose a health risk to patients.
Biocompatibility review under ISO 18562 guidelines
The client commissioned bibra to review a biocompatibility report following feedback from US FDA.
Toxicological risk assessment of leachables from a combination product
The client was developing a ready-to-use (RTU) process for the administration of a viral-based product in a clinical setting. Bibra was requested to assist with the assessment of extractables during the development phase and leachables in the final RTU process - viral vector product.
Biocompatibility evaluation of a series of autoinjector medical devices
The company manufactures a range of parts for use as components in a variety of medical devices.
Determining a suitable read-across surrogate for a pharmaceutical impurity
Following analytical studies on an intravenous drug product, an organic leachable from the container closure system (CCS) was detected, identified and quantified.
Evaluating the health risks posed by extractables and leachables from an ENDS device
In order to market their latest product in the United States, the client was intending to submit a Premarket Tobacco Product Application (PMTA) for a pod-based ENDS device.
Toxicological risk assessment of leachables from a syringe medical device
The company had commissioned leachables studies on a syringe medical device intended for flushing of intravenous catheters/tubing with saline. The leachables profile was examined at two time points (day 0 and about 2 months) and numerous substances were detected at low concentrations.
Evaluation of the endocrine-disrupting potential of a plant protection product
The Plant Protection Products Regulation (EC) No 1107/2009 is amended by Regulation (EU) 2018/605, requiring that information on the potential endocrine-disrupting properties of such products must be collated and evaluated. The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) have published “Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009”, detailing the performance of such hazard identification, together with an Excel spreadsheet to be used as a template for gathering the necessary information on “human and animal health” and “non-target organisms”.
Hazard characterisation of several e-liquid ingredients
The client is required to provide regulatory authorities with up-to-date toxicological information related to the ingredients used in their products. Bibra were provided with a list of several substances and asked to produce a hazard review (considering the requirements of the European Tobacco Products Directive, TPD2) for each.
Literature Review Report in support of a plant protection product active substance regulatory submission
The approval or re-registration of pesticide active substances (Plant Protection Products) under Regulation (EC) No 1107/2009 Article 8(5) requires applicants to submit dossiers containing scientific peer-reviewed open literature on the active substance and its relevant metabolites and impurities, dealing with side-effects on human health, the environment and non-target species, published within ten years of the date of dossier submission.