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.
Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms
Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.
the real picture of how biopharmaceuticals develop for market readiness
…compact, pithy….[The author] put his own unique stamp on this volume to complete the real picture of how biopharmaceuticals develop for market readiness."-Applied Genetics News, 1997
Introduction to the Development of Biopharmaceutical Parenteral Dosage Forms, John A. Bontempo
Fermentation Process Events Affecting Biopharmaceutical Quality, Anthony S. Lubiniecki
Development of Recovery Processes for Recombinant Proteins and Peptides, Paula J. Shadle
Preformulations Development of Parenteral Biopharmaceuticals, John A. Bontempo
Formulations Development, John A. Bontempo
The Analytical Techniques, Basant G. Sharma
Membrane Filtration Technology, Forrest Badmington
Considerations for Elastomeric Closures for Parenteral Biopharmaceutical Drugs, John A. Bontempo