Lyophilization of Small-Molecule Injectables: an Industry Perspective on Formulation Development, Process Optimization, Scale-Up Challenges, and Drug Product Quality Attributes
Arun Butreddy, Narendar Dudhipala, Karthik Yadav Janga, Rajendra Prasad Gaddam
Topics & Concepts
Process engineeringQuality by DesignCritical quality attributesSublimation (psychology)Active ingredientProcess optimizationSCALE-UPNew product developmentFreeze-dryingProcess developmentBiochemical engineeringComputer scienceChemistryEngineeringChromatographyChemical engineeringMedicineBusinessMarketingPsychologyPsychotherapistClassical mechanicsPhysicsPharmacologyProtein purification and stabilityDrug Solubulity and Delivery SystemsSafe Handling of Antineoplastic Drugs