Athenecia Faggins of Minaris Advanced Therapies discusses raw material qualification, supplier management, testing, and risk control for advanced therapy manufacturing.
|Articles|July 12, 2023
Are Nitrosamines a Concern for Biologic Manufacturers
Author(s)SGS
This article provides an assessment of nitrosamine contamination specifically in biologics and contrasts the potential risks between these product types.
Related to this article
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.
Dualitas will screen over 300,000 bispecific combinations for Roche, backing a deal worth up to $1 billion in immunology research.
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.