Lipid-based formulations are gaining global awareness, notably with lipid nanoparticles (LNPs) being a key component in several current COVID-19 and mRNA vaccines. Lipid-based formulations, including liposomes and LNPs, are an effective drug delivery system for a variety of active pharmaceutical ingredients (APIs), notably for complex parenteral drug products including cancer, viral, and gene therapeutics. In this podcast, we discuss how Emergent has been involved in the manufacturing of lipid-based formulations over the past two decades, along with factors to consider when partnering with a CDMO for lipid-based formulation manufacturing.
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.
Sanofi's Dr Jack Prior detailed a data maturity framework for biologics manufacturing, while FDA and Gilead panelists debated risk-based AI validation.
FDA's consumer safety officer, Jason Chancey, detailed real inspection findings, such as taped gaskets and delayed retesting, behind sterile facility deficiencies.