Questions Answers W911QY-21-R-0021 10 May 2021.pdf

This document contains a solicitation for stability testing services of recombinant botulinum and plague vaccine materials. The U.S. Army Contracting Command - Aberdeen Proving Ground, on behalf of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, is seeking stability testing of drug product, drug substance, reference materials, recombinant botulinum A/B vaccine materials, and recombinant plague F1V vaccine materials over a five year period of performance including one base year and four option years. Testing will include 3, 6, and 12 month stability testing of critical material lots and reagents in anticipation of ongoing and future activities. Interested parties must be capable of successfully executing or managing the required stability testing in compliance with FDA cGMP regulations and ICH guidelines. Data generated under the contract will be designated as controlled unclassified information. The solicitation is seeking a single firm fixed price contract to be awarded to a single responsible offeror.