Respiratory Illness Live Virus Fill / Finish Services

The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), seeks to establish Medical Countermeasure Fill / Finish capabilities to facilitate Live Virus/ Vectored Vaccine Medical Countermeasure (MCM) product development towards licensure. BARDA has a specific need to create core services to support cGMP and non-GMP filling and finishing of a variety of Medical Countermeasure products; small molecule, large molecule, live virus, lyophilized, pre-clinical, clinical, at pilot and commercial scale. BARDA needs Live Virus/ Vectored Vaccine Medical Countermeasure Fill / Finish core services for BARDA-sponsored product developers and manufacturers that may not have the appropriate or adequate manufacturing facilities or expertise. Additionally, during a public health medical emergency, Medical Countermeasure Fill / Finish services beyond current Government capacities may be needed to provide finished products rapidly to address the medical emergency. Through a set of contractual agreements, BARDA will establish Fill / Finish Manufacturing capabilities and capacities in order to provide a wide-array of live virus/ vectored vaccine product services to meet BARDA requirements. BARDA will coordinate the activities as they are awarded under this IDIQ contract. As directed by Task Order(s), contractors shall provide fill and finish services to support the development of live virus/ vectored vaccine Medical Countermeasure candidates and/or other MCMs as identified. Once the contractor is established as a live virus/vectored vaccine fill and finish service provider, other services may be requested via task order. Examples of other products which could potentially be requested are small molecule sterile injectables, large molecule sterile injectables, monoclonal antibodies, pre-clinical, clinical, and FDA approved MCMs. Fill / Finish services can also be requested for rapid response during a public health emergency. Expectations of Fill / Finish services and timelines will be specified in the Task Order (e.g. routine or urgent). Contractors will provide a wide range of fill and finish services, relevant to BARDA's vision to create a nation with the capability to respond quickly and effectively to natural and emerging threats by providing a range of fill and finish services, which can be used by BARDA and BARDA's development partners. The two objectives of the requirement are as follows: Objective 1: Fill / Finish Services: Contractors shall provide technology transfer and fill and finish services of live virus/ vectored vaccine and other types of MCM products that include the capability to process clinical investigational lots, engineering lots, process validation lots, and commercial-scale lots. Services may include, but are not limited to: technology transfer, lyophilization development, analytical testing, process optimization, process validation, formulation, filling, labeling, packaging, and distribution. Services may be provided to support the fill and finish of pharmaceuticals including parenteral drug products, monoclonal antibodies, recombinant proteins, antitoxins, and vaccines. As per the USG requirement, these liquid, lyophilized, or powder drug products may be filled and finished as prefilled syringes or sprayers, cartridges, auto-injectors, single dose or multi-dose vials. Objective 2: Rapid MCM Response Readiness: Contractors shall augment the existing US-based vaccine fill and finish infrastructure surge capacity for medical countermeasures, emerging infectious diseases, and other threats of known and unknown origin during a public health emergency, as described in Objective I. Once a public health emergency has been declared, the Contractor shall provide fill and finish services in response to a USG T/DOR. The T/DOR will outline a target timeline for completion of services to address the ongoing public health emergency. The USG anticipates that there may be other life-saving products being produced for commercial needs at the selected contractors' facilities. The delivery schedule for medical countermeasures will be negotiated between the USG and the contractors on a case by case basis to ensure supply of all priority life-saving products is maintained at appropriate levels. The Government intends to have a full & open competition for this requirement in the form of an RFP. This synopsis is not the RFP. The RFP itself is anticipated to be posted in, or after, February 10, 2016. The Government expects to make 1 or more awards, subject to the availability of funds. The due dates for proposals will be specified in the RFP itself.