A review and discussion. This article was written to provide the basic approaches and techniques used to design and develop dosage forms of proteins. To develop dosage forms means not only to generate a viable formulation, but also to identify a final packaging system, to design and scale up a quality manufacturing method, and to employ valid measurements to assure product quality. In addition, in this area of globalization, formulations must be developed that are acceptable from a regulatory standpoint throughout the world. Antimicrobial preservation, packaging components, container-closure integrity, clin. trial manufacturing, and development history reports. The authors have reviewed the literature and have selected the articles which provide both intensive anal. and extensive information on solving protein formulation and other product development problems.