Indenos (LMP744, NSC 706744) for Injection

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 15LM092 with the following changes: The specification should be prepared in consultation with COR prior to manufacturing with emphasis on the endotoxin level to be less than 0.156. The Contractor will produce sterile product consisting of 1.0 mg/mL, 15 mL fill in a 20 mL size vial under this task order following FDA stated cGMP condition. After being manufactured and QC tested according to new specification, label the product using house-made labels (similar to Lot15LM095 and ship the product to our clinical repository in Rockville, MD and the NCI shelf-life contractor. The bulk drug will be provided by NCI. The Contractor shall perform incoming identity test of the bulk drug using UV assay.