Extractable and leachable (E&L) testing on drug container closure systems (CCS) is a required component of marketed drugs. Gradient has extensive expertise in assessing the potential patient risks of E&L chemicals. Our team includes board-certified toxicologists, health scientists, and chemists who provide our clients with fit-for-purpose assessments that address the toxicological evaluation component of CCS qualification. We are skilled in assessing data-poor chemicals and chemical classes through well-developed in silico and read-across methodologies, offering our clients responsive, expert advice and services.
Toxicological Risk Assessments on Leachable Compounds from a Dermal Drug Container
For a pharmaceutical testing laboratory, Gradient derived a permitted daily exposure (PDE) and tolerable contact level (TCL) for several impurities in a dermally administered drug product in accordance with ICH methodology. Gradient relied on publicly available scientific literature and in silico tools to derive the PDEs and TCLs, which were used by the drug manufacturer to support and justify the manufacturing specification of the drug product.
Patent Litigation Case for a Drug-Delivery Medical Device
For a patent litigation case, Gradient evaluated the safety profile of a polymeric coating for application in a syringe pre-filled with a biological drug product. We reviewed toxicity data and protein adsorption properties of the polymeric coating, adhering to the biological safety assessment framework detailed in the ISO 10993 series of standards. Our findings were prepared in a written declaration and presented in an oral deposition.
Toxicological Risk Assessment of Drug Container Label
For a pharmaceutical company, Gradient conducted a toxicological risk assessment of chemicals identified as migrating from a printed ink label of an over-the-counter ocular drug product. We provided the client with a report that was used to evaluate the safety of the label.
Toxicological Risk Assessment on Leachable Compounds in Parenteral Drug Product
For a pharmaceutical testing laboratory, Gradient derived permitted daily exposures (PDEs) and toxicology-based exposure limits for potential leachable impurities in a parenterally administered drug product. We conducted a toxicological risk assessment of the identified chemicals for systemic toxicity, genotoxicity, carcinogenicity, and developmental and reproductive toxicity, and used read-across to analog chemicals where necessary. Based on the results of these evaluations, we proposed chemical-specific PDEs, as appropriate.
