Request for Information - US Army Medical Research and Materiel Command Special Immunizations Program

1.0 GENERAL INFORMATION: Document ID#: W81XWH-RFI-SIP NAICS: 325414 Agency: U.S. Army Medical Research and Materiel Command (USAMMDA) Location: Fort Detrick, MD 2.0 DISCLAIMER: This is a Request for Information (RFI) as defined in FAR 15.201(e) to ascertain whether commercial services exist that provides the capabilities described in this RFI. This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. All information received in response to this RFI will be treated as business confidential information. Nonetheless, submitters should properly mark their responses if the information is confidential. Responses to the RFI will not be returned. In keeping with the policy and procedures of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained. 3.0 RFI RESPONSE AND DUE DATE: 05 June 2017, by 4:00 P.M. EST 4.0 SUBJECT: The 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. 5.0 DESCRIPTION: 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. It is currently stored under nitrogen in 20 mL glass vials with rubber vial stopper and aluminum crimp cap. The reconstitution volume is 11 mL (sterile water for injection); producing a volume sufficient for ~ 20 human doses (0.5 mL per dose). Vaccine vials are stored and maintained at -20 - 10'C before reconstitution. 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 indicated human dose volume should remain at 0.5 mL, and will contain approximately 5x104 plaque forming units (pfu) of MP12 vaccine virus per 0.5 mL dose. We anticipate the vaccine will be reconstituted, pooled, aliquoted, lyophilized, and sealed under nitrogen. 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. The facility and the procedures employed for re-vialing and testing will be 21 CFR 211 compliant for current Good Manufacturing Practices (cGMP). 6.0 CONTRACTING OFFICE ADDRESS: ATTN: MCMR-AAA-SD 820 Chandler Street Fort Detrick, MD 21702-5014 7.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish a white paper addressing the above capability (maximum of five pages, not including cover page, index, list of references, or attachments). The subject header of the email for submission of questions and/or the RFI response shall be: SIP RVF MP-12 Revialing. All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately. Submission should include the following information: 7.1 Description of the facility, to include capability for vaccine reconstitution, pooling, sterile fill-finish, lyophilization, vaccine storage, and ability to support lot-release and stability testing. 7.2 Describe vaccine vial processing capacity. Can the facility reasonably produce the maximum number of vials that may be needed (20,000 single-dose vials)? Or, would processing a smaller number of vials be optimal and/or required? 7.3 Please provide a recommended North American Industry Classification System (NAICS) code and Product Service Code (PSC). 8.0 QUESTIONS: This RFI is a request for a white paper. No questions will be entertained at this time. 9.0 INSTRUCTIONS TO RESPONDERS: Responders shall fill out and submit Attachment 1. Please submit responses no later than the aforementioned due date. Preferred media is electronic copies in Microsoft Word. Preferred method of submission is via email. Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. Phone calls will not be entertained. It is the responsibility of any potential offeror to monitor this site for the release of any solicitation or synopsis in relation to this request.