The U.S. Army Medical Research and Materiel Command (USAMRMC) Special Immunizations Program (SIP) currently offers Investigational New Drug (IND) products to both military and civilian personnel at risk for pathogen and toxin exposure.
The current portfolio of SIP vaccines consists of legacy products produced primarily by the Salk Institute in the 1960’s to the 1980’s that are not on a path for FDA licensure. There is a current need to have one of these vaccines, originally vialed in multi-dose format, re-vialed into single-dose vials.
MP-12 is a live-attenuated vaccine developed to produce a protective immune response against Rift Valley Fever Virus (RVF), a virus endemic to sub-Saharan Africa. The vaccine is a lyophilized, IND product produced by The Salk Institute Government Services Division (TSI-GSD) in the nineteen eighties.
The SIP is looking for a facility with sterile fill-finish and lyophilization capability to re-vial between 250 and 1000 20 mL vials to single-dose vials (5000-20000 vials). The number of vaccine vials processed will be specified at a later time and will depend on capacity of the facility, cost, and needs of the product sponsor.
The facility should indicate the capability to perform, support, or otherwise arrange for lot-release and stability testing that could include sterility, endotoxin, mycoplasma, potency (virus titer measurement by plaque assay), and other assays as agreed upon.
Further details are available via Solicitation Number: W81XWH-RFI-SIP2. The response deadline is Jun 05, 2017 4:00 pm Eastern.