Strategies for Setting Patient-Centric Commercial Specifications for Biotherapeutic Products
Margaret Ruesch, Luca Benetti, Eileen Berkay, David Cirelli, Neha Frantz, Martin H. Gastens, Wayne P. Kelley, Juliana K. Kretsinger, Mike Lewis, Shawn Novick, Barbara L. Rellahan, Laura Pack, Corné J.M. Stroop, Ann Subashi, Ping Yin, Mingyong Zeng, John T. Stults
Topics & Concepts
Quality (philosophy)Product (mathematics)Flexibility (engineering)Product design specificationRisk analysis (engineering)Computer scienceSupply chainProcess (computing)New product developmentQuality by DesignProcess managementBusinessProduct designMarketingOperating systemStatisticsMathematicsPhilosophyGeometryEpistemologyViral Infectious Diseases and Gene Expression in InsectsBiosimilars and Bioanalytical MethodsProtein purification and stability