As the demand for monoclonal antibodies (mAbs) continues to grow across therapeutic, diagnostic, and industrial applications, biomanufacturers face mounting pressure to achieve higher productivity, increased process robustness, and improved scalability. Upstream and downstream operations, particularly media and buffer preparation, ingredient dissolution, and process homogeneity, play a critical role in ensuring consistent performance and maximizing overall yield. However, traditional mixing technologies often struggle to meet the evolving needs of intensified and flexible bioprocessing strategies while keeping operators safe and protecting the products from contamination risks.
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.