Stress Factors in Protein Drug Product Manufacturing and Their Impact on Product Quality
Tapan K. Das, Alavattam Sreedhara, James D. Colandene, Danny K. Chou, Vasco Filipe, Christoph Grapentin, Jim Searles, Twinkle R. Christian, Linda O. Narhi, Wim Jiskoot
Topics & Concepts
Critical quality attributesQuality by DesignQuality (philosophy)Product (mathematics)Manufacturing processComputer scienceProcess (computing)Manufacturing engineeringRisk analysis (engineering)New product developmentBiochemical engineeringReliability engineeringBusinessEngineeringMaterials scienceMathematicsEpistemologyComposite materialMarketingGeometryPhilosophyOperating systemProtein purification and stabilityViral Infectious Diseases and Gene Expression in InsectsBiosimilars and Bioanalytical Methods