title: New FDA draft guidance on immunogenicity.
abstract: A "Late Breaking" session was held on May 20 at the 2013 American Association of Pharmaceutical Scientists-National Biotech Conference (AAPS-NBC) to discuss the US Food and Drug Administration's (FDA) 2013 draft guidance on Immunogenicity Assessment for Therapeutic Protein Products. The session was initiated by a presentation from the FDA which highlighted several key aspects of the 2013 draft guidance pertaining to immunogenicity risk, the potential impact on patient safety and product efficacy, and risk mitigation. This was followed by an open discussion on the draft guidance which enabled delegates from biopharmaceutical companies to engage the FDA on topics that had emerged from their review of the draft guidance. The multidisciplinary audience fostered an environment that was conducive to scientific discussion on a broad range of topics such as clinical impact, immune mitigation strategies, immune prediction and the role of formulation, excipients, aggregates, and degradation products in immunogenicity. This meeting report highlights several key aspects of the 2013 draft guidance together with related dialog from the session.
authors.affiliation: Mercer University, 3001 Mercer University Drive, Atlanta, Georgia, 30341, USA, 10909990@live.mercer.edu.
authors.forename: Ashwin
authors.initials: A
authors.lastname: Parenky
authors.forename: Heather
authors.initials: H
authors.lastname: Myler
authors.forename: Lakshmi
authors.initials: L
authors.lastname: Amaravadi
authors.forename: Karoline
authors.initials: K
authors.lastname: Bechtold-Peters
authors.forename: Amy
authors.initials: A
authors.lastname: Rosenberg
authors.forename: Susan
authors.initials: S
authors.lastname: Kirshner
authors.forename: Valerie
authors.initials: V
authors.lastname: Quarmby
mesh_terms: D000818:Animals; D017408:Guidelines as Topic; D006801:Humans; D011506:Proteins / Q000009:adverse effects* / Q000276:immunology* / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011506:Proteins