Issues in Development of Biodrug Delivery Systems
INTRODUCTION Recent reviews list more than 400 biotechnology-based pharmaceuticals either registered, in clinical trials, or undergoing review by the regulatory agencies for the treatment of nearly 150 diseases including cancer, infectious diseases, autoimmune diseases, and deficiency diseases (1,2). The area of biopharmaceuticals such as proteins and nucleic acid-based therapeutics has developed significantly during the last decade. For the pharmaceutical scientists, who aim at formulating biopharmaceuticals as products with ideal therapeutic effects and optimized storage characteristics, these drugs are highly challenging. Because of the unique physicochemical characteristics related to the structure of the peptide and protein, the formulation development is in many ways different from conventional low molecular drug formulation development.