MANUFACTURING OF A LYOPHILIZED PARENTERAL DOSAGE FORM OF THE INDOLOQUINONE ANTITUMOR AGENT EO9 FOR PHASE-II CLINICAL-STUDIES IN THE SETTINGOF A HOSPITAL PHARMACY

The manufacturing process for 28 batches (5555 vials) of a parenteral Lyophilized dosage form of the investigational cytotoxic drug EO9 with in the setting of a hospital pharmacy is described. Quality control of lyophilized EO9 indicated that all batches conformed to the specifica tions for the finished product. Long-term stability data of EO9 finish ed product are presented. In addition, the antimicrobial activity of E O9 against several microorganisms was determined. The implications of Good Manufacturing Practice (GMP) with respect to such a relatively la rge production in a small manufacturing site are discussed.