Self-Contained Cartridge for Thin Layer Chromatography Based Quantification of Chemotherapy Concentration in Human Clinical Plasma Samples

Therapeutic drug monitoring enables personalized cancer medicine by dosing patients with chemotherapy based on the patient’s own unique rate of drug clearance and metabolic degradation. These rates significantly influence the plasma concentration which influences patient outcomes. This is especially true for the commonly used chemotherapy agent doxorubicin. The current state-of-the-art method used to determine drug concentrations in blood is high-performance liquid chromatography (HPLC). However, the need for specialized equipment and expertise restricts the use of HPLC for point-of-care applications, limiting the clinical impact of TDM. To address this challenge, we demonstrate here a new self-contained thin layer chromatography (TLC) system that uses a single step plasma drug extraction from plasma along with a self-contained hermetically sealed TLC cartridge design. The system effectively separates the chemotherapy agent DOX from its metabolites and other blood components during TLC plate development, while preventing release of silica dust from the TLC plate and mobile phase fumes. In evaluation with clinical samples, 75% of TLC measurements aligned within 15% of HPLC-derived values, and all fell within 16%, fulfilling FDA acceptance criteria for a bioanalytical system using chromatographic methods. We demonstrate that this process can be successfully conducted inside the self-contained cartridge that hermetically seals the TLC plate. Future automation of the cartridge handling and imaging would allow this process to be safely performed in a clinical setting with minimal interaction from clinical staff.