Analysis of the efficacy of an automated TheraCys BCG preparation

A standard pharmaceutical agent used in the treatment of bladder cancer, TheraCys BCG, poses a high toxicity risk to its surrounding environment, as well as, the individuals preparing it. The main component of the drug is the infectious bacteria, Bacillus of Calmette and Guerin (BCG), in a lyophilized form that is manually reconstituted by suspension in a saline buffer. The final preparation requires withdrawing the suspension into a syringe before placing it in a final buffer for administration, which introduces measurement, cross-contamination and inactivation challanges to the process. The DRUG-device serves to eliminate all these factors by automating the reconstitution process. A vertical actuating syringe is mounted above a rotating vial rack that contains: the lyophilized BCG, saline buffer and final buffer solution. The step-wise reconstitution process is then executed through a computer initiated sequence controller. A suspension of BCG is expected to contain an average of 10.5 plusmn 8.7 colony forming units per vial, which the device has shown to accurately produce using suspended granular molecular sieves as a check-out. Success with the automation of the TheraCys BCG preparation opens possibilities for use of this device with other reconstitutionable drugs such as Mitomycin and Intron A.