This app note demonstrates automation of the OligoWorks SPE Microplate Kit and protocol using the Andrew + pipetting robot and presents quantitative LC-MS data across a diverse set of oligonucleotide therapeutics spiked into plasma. Quantitative LC-MS results from the automated detergent-free workflow are compared to results from manual processing demonstrating equivalent performance as well as excellent reproducibility, underscoring the benefits of automating the OligoWorks SPE Microplate Kit: a streamlined sample extraction workflow, reduced errors, reproducible analytical method performance and enhanced lab productivity.
Athenecia Faggins of Minaris Advanced Therapies discusses raw material qualification, supplier management, testing, and risk control for advanced therapy manufacturing.
FDA compliance officers detailed 2026 guidance updates, online drug sale enforcement, and a first-of-its-kind AI-related warning letter at the PDA/FDA Joint Regulatory Conference.
Sanofi’s Jack Prior discusses how biopharmaceutical manufacturers can assess whether process data is ready for human and AI use, and the role of data quality, accessibility, governance, and AI in manufacturing.
Panelists from FDA, Genentech, and Minaris discussed raw material risk, supplier oversight, and at-risk release strategies for advanced therapies at the PDA/FDA Joint Regulatory Conference.
FDA's Francis R.W. Godwin (CDER) and Kathleen Jones, PhD (CBER) detail a record pace of drug warning letters and the CGMP deficiencies most commonly cited in biologics facility inspections.