Evaluation of DMSO extraction efficiency compared to other solvents on representative polymeric materials used in...

Single-use systems (SUS) are increasingly employed in biopharmaceutical manufacturing, including advanced therapy medicinal products (ATMP) and antibody-drug conjugates (ADC). Dimethyl sulfoxide (DMSO), commonly used at 5-10 % in cell and gene therapy (CGT) and up to 20 % in ADC processes, is not routinely included in standard extractables and leachables (E&L) solvent panels. This study evaluates whether DMSO provides unique extractables compared to conventional solvents. Twelve controlled extraction studies were reviewed, encompassing SUS components exposed to various solvents under worst-case conditions. Extracts were analyzed for volatile, semi-volatile, and non-volatile organic compounds using HS-GC-MS, DI-GC-MS, and LC-UV-MS, with elemental impurities assessed by ICP techniques. Unique compounds-those detected exclusively in one solvent-were identified to assess solvent-specific extraction behavior. Results indicate that 10 % DMSO does not yield unique compounds or higher extractable concentrations compared to water or 50 % ethanol. Solvents with higher organic content (≥50 % ethanol) consistently demonstrated greater extraction efficiency, confirming their role as worst-case conditions. These findings suggest that inclusion of 10% DMSO in standard E&L panels may not be necessary for CGT processes, while additional comparative data are needed for ADC applications involving 10-20 % DMSO. Broader industry data sharing and harmonization are recommended to support risk-based solvent selection and regulatory compliance.