Development of Biopharmaceutical Parenteral Dosage Forms by C... - 9780367400910

CRC Press

This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. \nWritten by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms\n--details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process \n--describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization \n--considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stabilito