A--Monoclonal Antibody Production for Infectious Disease Studies.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The purpose of this mofication is to provide answers to questions that were submited in accordance with this Combined Synopsis/Solicitation. No further questions will be accepted. Questions and Answers for W81XWH-13-T-0171 1.) What is the formulation of the buffer composition noted on page 8, under Task number 3? Question #1 Answer - The Government believes this can be determined as part of the pilot scale batch. We would prefer not to lock ourselves into one particular buffer if other alternatives could be used. On previous shipments working samples were shipped in Phosphate Buffered Saline at a pH of 7.4 (frozen on dry ice) for example. 2.) Does the Government have particular physiocochemical properties for the mAb they desire to see as noted in Table 1, page 11, under Performance Standard? Question #2 Answer - At a minimum pH, buffer used, appearance, purity and endotoxin physiochemical properties are requested in accordance deliverables on the Performance Work Statement.