Procurement of Good Manufacturing Practice (GMP) QS-21   2

Background
The Walter Reed Army Institute of Research (WRAIR) is conducting market research to determine whether a commercial solution for the manufacturing and delivery of QS-21, a lyophilized powder derived from Quillaja saponaria, exists. The product must be manufactured under current Good Manufacturing Practice (cGMP) conditions in compliance with 21 CFR part 210 and 211. The vendor is required to accommodate an onsite audit and enter into a quality agreement with the Office of Regulatory Affairs (ORA) and the Walter Reed Army Institute of Research (WRAIR).

Work Details
The contract requires the procurement of 750 mg of QS-21, meeting specific purity, appearance, identification, and other characteristics as outlined in the provided table. The product shall be placed on a stability plan of a minimum of two years. Additionally, specific delivery requirements include packaging in at least two different containers, compatible with QS-21 preferably type 1 glass, and shipping under temperature-controlled conditions with 2 temperature monitors.

Place of Performance
The delivery location is Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF), Forest Glen Annex, Building 501, Silver Spring, MD 20910.