Chris Waine's case studies
Non-clinical overview
Case study
Following the reformulation of an emollient, an increased level of an impurity was detected compared with the previous formulation. Based on this, the client proposed a new shelf-life specification limit for the impurity. Click through to read more about how we dealt with this interesting project.
A human health risk assessment of detected extractables
Case study
The client produces a foam-based drug product that patients can self-administer from an aerosol cannister. According to the manufacturer of the container-closure-system (CCS), several compounds (including some unknown constituents) were identified as extractables from two components of the cannister that directly contact the drug product.
Registration of a novel biocidal active substance
Case study
EU manufacturers of biocidal products are required, under the Biocidal Products Regulation (BPR), to submit a dossier of information to the European Chemicals Agency (ECHA). Before a biocidal product can be registered, however, the active substance must also be approved by the Agency.
Updating REACH dossiers following ECHA Evaluation decisions
Case study
Manufacturers of chemicals in, or importers into, the European Union are required under the REACH regulation to submit a dossier of information on their substances to the European Chemicals Agency (ECHA). The Agency can, after evaluating the information provided by the registrant, require the company to update or amend their dossier, including with the addition of new experimental data. This is called a “Compliance Check decision”
Δ9-THC – a low-level impurity in food
Case study
The client identified a potential contamination risk in certain of their (non-cannabinoid) food products. Low levels of (-)-trans-delta-9-tetrahydrocannabinol (Δ9-THC) – the main psychoactive component of cannabis – were analytically determined in several foodstuffs, from a specific production line.
Literature review and in silico prediction of metabolites
Case study
As part of their overall regulatory requirements, the client was asked to provide information on the known or predicted metabolites of a number of ingredients in their products. This formed part of a broader programme of work that bibra conducted for this client.
In silico prediction of genotoxicity and carcinogenicity
Case study
As part of their overall regulatory requirements, the client was asked to provide an assessment of the known or predicted genotoxicity and carcinogenicity of a number of ingredients in their products. Bibra were provided with a list of several substances and asked to carry out this work following the genetic toxicology in silico (GIST) protocol.
In silico assessment of impurities in a pharmaceutical
Case study
The client presented us with the structures of a number of impurities in a medicine currently in development for advanced cancer indications.
REACH registration of nearly 100 related metal compounds
Case study
Manufacturers of chemicals in, or importers into, the European Union are required under the REACH regulation to submit a dossier of information on their substances to ECHA.
PDE for a leachable in an intravenous pharmaceutical
Case study
ICH defines a Permitted Daily Exposure (PDE) as a pharmaceutically acceptable intake “protective of public health for all patient populations” and provides specific guidance on the derivation of PDEs for threshold toxins identified as residual solvents (Q3C guideline) and elemental impurities (Q3D guideline) in pharmaceuticals.