REQUEST FOR INFORMATION - Formulation and Filling of Live Vectored Vaccines (LVV)

REQUEST FOR INFORMATION DATE: 11-21-2014 TITLE: Formulation and Filling of Live Vectored Vaccines (LVV) RFI No.: 15-BARDA-LVV_Fill-RFI-001 This is a REQUEST FOR INFORMATION (RFI) and is issued for informational and planning purposes only. This RFI is NOT a Request for Proposal (RFP), a Request for Quotation (RFQ), an Invitation for Bids (IFB), a Solicitation, or an indication that the Department of Health and Human Services (DHHS) will contract for the items contained in this RFI. The information requested herein will be used within DHHS', Biomedical Advanced Research and Development Authority (BARDA), and the Office of Acquisition Management, Contracts & Grants (AMCG) to facilitate decision making and will not be disclosed outside of the agency. Please note that DHHS is NOT responsible for any costs incurred by interested parties in responding to this RFI. Background: As we continue to support efforts to address the recent Ebola epidemic in West Africa, the Government is interested in information from vendors relative to the Formulation, Fill and Finish of new drug products. This information includes vendor's capability to complete transfer and manufacture of cGMP formulation, filling and finishing activities at target concentrations, which will be defined as part of the transfer process, prior to GMP manufacturing activities. These new products are Live Vectored Vaccines (LVV), and because these products are in very early development stage, there is a high likelihood that the products will have limited stability data, time out of refrigeration data, and to best ensure product quality, will require freezing and storage at low temperatures (< - 80C). There are multiple products being considered. In addition, some regulatory agencies may require that these processes take place in a Biological Safety Level 2 (BSL2) facility. The Government is seeking vendor information/capability on the filling of products similar to the ones listed below: 1. RVSVdG eBOV vaccine replication-competent live virus vaccine utilizes a recombinant Vesicular Stomatitis Virus (rVSV) lacking the native VSV glycoprotein (?G) and bearing the glycoprotein (GP) of ZEBOV, which is the target of protective immunity. The rVSV?G ZEBOV is an attenuated virus and capable of limited replication after administration, which is believed to be the basis for the potent immunogenicity of this vaccine vector. 2. rVSVN4CT1-Z-EboV Vaccine utilizes attenuated replication-competent rVSV vector that is injected IM, it undergoes limited propagation at the injection site and in the local draining lymph nodes, but does not spread to other organs and tissues. Drug substances are currently being developed and manufactured to support these, and other similar LVV products. Products will require formulation to set target concentrations. Final concentrations will be provided by the U.S. Government prior to GMP manufacturing. The final filled containers will require labeling, storing and shipping. Final release of the lots will be performed by the original intellectual property owner, or their designee. Submission Information / Instructions: The North American Industry Classification System (NAICS) Code is 325414. It is requested that interested parties submit a capability package to include the following: 1. Contractor name, address, phone number, business size, contact person; 2. Brief description of contractor experience; 3. Description of work performed relative to the filling of similar products as listed above; 4. Would the filling of similar products as listed above be undertaken at your facility or subcontracted out? And 5. How much advanced notice, if any, would be required to accommodate the filling for similar products? Please limit the capability package to no more than eight (8) pages. The capability package must be clear, concise and complete. Please submit an electronic copy of your capability package no later than: 12:00 PM, EST on Friday, December 5, 2014. Your capability package shall be submitted to the following addresses: quintin.hackshaw@hhs.gov and tammy.mcleod@hhs.gov All questions concerning this RFI must be submitted via e-mail to both e-mail addresses listed herein. Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. To aid DHHS, please segregate and clearly mark proprietary information. Please be advised that all submissions become the property of the Government and will not be returned. This RFI is in accordance with FAR 52.215-3 Request for Information or Solicitation for Planning Purposes (Oct 1997), as such, any information received will be for the purpose of planning only.