CHEMISTRY, MANUFACTURING, AND CONTROLS (CMC) DEVELOPMENT OF NES-100 AS A NASAL SPRAY OF A NEW ANALGESIC

Leidos Biomedical Research, Inc., Frederick MD

Investigators

Abstract

This is to award the contract to perform all the tasks listed here. Offeror is referred to contractor/subcontractor hereafter. NES100 is formulated by high pressure homogenization of MET and LENK to form nanoparticles, followed by spray drying to produce MET-LENK microparticles. The microparticle powder is then filled into a nasal device. The device will be filled with the MET-LENK to be fired into the nares by using a propellant gas or any other means. MET-LENK nasal powder will be contained in the device of interest. The offeror is to bring the candidates of devices for consideration. NES-100 drug products (Device with spray-dried powder MET-LENK), executed manufacturing batch records, and stability studies will be used in support of the IND application. NCATS will provide GMP grade API of LENK peptide powder and GMP/non-GMP grade of MET. NCATS will also provide the certificate of analysis, preliminary HPLC method, MSDS (Material Safety Data Sheet), detailed formulation process, and some specification testing methods. The contractor/subcontractor will be responsible for providing all other consumable supplies, facilities and equipment to prepare nasal dosage form of NES-100 not listed here. All excipients are to be compendia grade (USP or NF) or FDA registered with Drug Master File.