Respiratory Illness Live Virus Fill / Finish Services

PROPOSED REQUIREMENT TITLE: HHS-BARDA-Sources Sought - Respiratory Illness Live Virus Fill / Finish Services ___________________________________________________________________ THIS IS A SMALL BUSINESS SOURCES SOUGHT NOTICE ONLY The Government is seeking qualified small business concerns and seeks to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUB Zone, service-disabled, veteran-owned , 8(a), woman-owned small businesses, or small disadvantaged businesses; and (3) size classification relative to the North American Industry Classification System (NAICS) code 325414. The small business size standard is 500 employees. Your response to the information requested will assist the Government in determining the appropriate acquisition strategy, including whether a small business set-aside is a possibility. This Sources Sought Notice (SSN) is not a Request for Proposal (RFP) and does not constitute a commitment by the United States Government (USG). The USG is currently conducting market research in accordance with Federal Acquisition Regulation, Part 10, to identify potential small business sources to fulfill the requirement and gather information on current capabilities within the market. All information submitted in response to this sources sought notice is voluntary and the USG will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the USG. Proprietary information submitted should be marked appropriately. All submitted information shall remain with the USG and will not be returned. 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), has a future requirement 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 would 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 potential 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. Anticipated minimum Mandatory Eligibility Criteria for this acquisition will be similar to the following: Offerors must show fill and finish of at least one live/live vectored infectious disease product under a FDA Investigational New Drug (IND), or FDA License application in the last 5 years in order to be considered for award. A fill and finish activity is deemed "complete" for purposes of this criterion when final release documentation is produced. For purposes of satisfying this Mandatory Criteria, "offeror" is defined as the "Prime Contractor" under a standard Prime Contractor sub relationship or, in the alternative, a member of a formal partnership or a formal joint venture (JV) arrangement under FAR 9.601(1). The mandatory criteria for eligibility must be met at the time of proposal submission. Offeror proposals that do not meet the mandatory criteria for eligibility will not be eligible for further evaluation. It is requested that respondents to this sources sought notice identify their interest by submitting the following information: 1. Existing live/ vectored virus filling presentations supported (vials, syringes, cartridges, bottles, etc.) 2. Size Ranges for each presentation (2-25 mL vials, 1-3 mL syringes, etc.) 3. Capacity for each filling presentation. 4. Ability to fulfill core services including, but not limited to: analytical testing development, scale-up, formulation, filling, finishing, technology transfer from 3rd party biopharmaceutical company(ies), process optimization, process validation, labeling, packaging, and distribution. 5. Items 1-4 above for non-live virus filling presentations. Respondents to this sources sought notice may identify their interest by submitting a capability statement, including primary contact information at the organization (name, email, address and telephone number) handling this sources sought notice, in the event HHS has additional questions or requires clarification of the submitted information. Responses are limited to 15 pages including appendices and attachments. All respondents and comments to this sources sought notice shall reference HHS-BARDA-Sources Sought - Respiratory Illness Live Virus Fill / Finish Services. Responses must be submitted NLT 2:00 PM EST on Friday December 11, 2015 to the following: Matthew McCord, Contract Specialist, at matthew.mccord@hhs.gov and Quintin Hackshaw, Contract Specialist at quintin.hackshaw@hhs.gov Contracting Office Address: Biomedical Advanced Research and Development Authority 330 Independence Avenue, SW, Room G640 Washington, District of Columbia, 20201 Mr. Matthew McCord, Contract Specialist Matthew.mccord@hhs.gov 202.260.0689 Mr. Quintin Hackshaw, Contract Specialist Quintin.Hackshaw@hhs.gov 202.260.0453