James Hopkins's case studies
Determining a Specific Migration Limit (SML) for a data-deficient compound identified in food labels
Case study
The client was informed by a supplier that a chemical compound with a worrying structure was present within a food label ink. Click to find out how we dealt with it.
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.
Summarising hazard data on food additives and contaminants
Case study
On a regular basis over a period of nearly 20 years, bibra has provided a multi-national company with first drafts, or updates, of concise reports on individual or groups of food additives and contaminants.
Derivation of a dermal HBEL for a hormone ester
Case study
Health-Based Exposure Limits (HBELs) are used to control risk when different medicinal products are manufactured in shared facilities.
N-Nitrosamines risk assessment for a pharmaceutical product
Case study
Bibra was asked to investigate two N-nitrosamines extracted from stoppers for vials used within the pharmaceutical sector.
Evaluation of the safety of two complex cosmetics ingredients
Case study
The client was interested in extending the conditions of use of two of its manufactured surfactants to cosmetics and requested a risk assessment in order to evaluate their safety in a range of rinse-off and leave-on products. The two surfactants are each a mixture of several different structurally-related chemicals.
Derivation of a Tolerable Daily Intake (TDI) for a chemical in Food Contact Materials (FCMs)
Case study
Food-Contact Materials (FCMs) encompass all materials and articles that come into contact with food as it is produced, packaged, stored and consumed. Experts from the European Food Safety Authority (EFSA) have stated that the safety of FCMs must be evaluated to ensure that their potential transfer to foods would not have any adverse effects on consumers . Under EU regulation (EC) 1935/2004, FCMs must not transfer their components into the foods in unacceptable quantities.
Derivation of an intravenous PDE for a common leachable
Case study
Chemicals that leach into drug products from processing or manufacturing equipment, drug delivery systems and/or packaging may pose a health risk to patients.
Toxicological risk assessment of leachables from a combination product
Case study
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.
Determining a suitable read-across surrogate for a pharmaceutical impurity
Case study
Following analytical studies on an intravenous drug product, an organic leachable from the container closure system (CCS) was detected, identified and quantified.