3. 5 kg GMP Lot of sPIF

This is not a Request for Proposals (RFP). This is a Pre-solicitation Announcement only. RFP No. NIHDA201800195, titled "3.5 kg GMP Lot of sPIF," will be issued via fedbizopps on or about June 5, 2018.

The Bridging Interventional Development Gaps (BrIDGs) program at the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH) assists researchers in advancing promising therapeutic agents through late-stage pre-clinical development toward an Investigational New Drug (IND) application and clinical testing.

BrIDGs is currently collaborating with BioIncept to develop Synthetic Preimplantation Fact (sPIF) as a potential treatment for Graft-Versus-Host Disease (GVHD).

The goal of this contract is for BrIDGs to acquire an additional 3.5 kg of cGMP sPIF to allow for additional studies to be conducted.

To accomplish this goal, the Government plans to solicit proposals from offerors that either have 3.5 kg of GMP sPIF available or are able to manufacture 3.5 kg (on net peptide basis) cGMP lot of sPIF peptide. If an offeror proposes to manufacture 3.5 kg GMP lot of sPIF, the offeror must have prior experience with manufacturing GMP sPIF on a kilogram scale or multi-hundred gram scale and must have an established manufacturing process and qualified analytical methods. These requirements are included to ensure continuity of science; because some of the prior lots of GMP sPIF have been used in toxicology studies and clinical studies, an impurity profile should be similar to the impurity profile of the previous lot (the impurity profile will be included in the RFP).

The Government anticipates awarding a single firm-fixed price contract.

Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.