Production of 50 mL fill of 1 mg/mL injectable LMP-744

Irisys, Inc., San Diego CA

Investigators

Abstract

THIS AGENT IS BEING DEVELOPED IN SUPPORT OF ONGOING PHASE I/II CLINICAL TRIALS, THEREFORE THE PRODUCT IS NEEDED TO BE PRODUCED UNDER THE GMP CONDITION USING THE PROCESS USED TO PRODUCE LOT NUMBER 15LM. The batch of product was produced by the contractor and sent to clinical repository. The shelf-life was also evaluated. The drug product will be used in the NCI clinical trials.