Core - Manufacturing, Quality And Analytical

Ray, Nitya

Abstract

The Manufacturing, Quality and Bioanalytical Testing Core (Core B) is responsible for PRO 140 production and testing in accordance with current Good Manufacturing Practice (cGMP). Core B also will contribute to the clinical studies of Project 1 by providing bioanalytical testing of patient specimens according to current Good Laboratory Practice (cGLP). This Core includes Quality Assurance oversight to ensure that the cGMP and cGLP activities are performed in accordance with all relevant federal regulations and industry practices such that the clinical-grade PRO 140 and laboratory data meet the highest standards of quality. The Core functions comprise four Specific Aims:
Specific Aim #1 : Manufacture PRO 140 in accordance with current Good Manufacturing Practice (cGMP).
Specific Aim #2 : Perform QC testing of PRO 140 to support product release and to ensure product stability.
Specific Aim #3 : Perform bioanalytical tests under current Good Laboratory Practice (cGLP) to support Phase 1b and Phase 2a clinical trials of PRO 140.
Specific Aim #4 : Provide QA oversight of manufacturing and test procedures to ensure compliance with cGMP and cGLP. Clinical-grade PRO 140 will be provided to Projects 1-3 so as to ensure that material of the highest quality is used throughout the IPCP, and to ensure comparability of data across the Projects. Prior to release, PRO 140 will be rigorously tested according to standardized and validated procedures. The Core will also provide critical bioanalytical support for the clinical trials of Project 2, and these analyses will examine PRO 140 serum concentrations, anti-PRO 140 antibodies, serum RANTES levels, and cell-based assays of immune function. The activities of Core B will be performed at Progenies Pharmaceuticals, Inc. by an experienced team of professionals with significant industry experience in each of the functional areas.