Establishing a Fill and Finish Network

PROPOSED REQUIREMENT TITLE: HHS-BARDA-Sources Sought -Fill and Finish Network-Jan 2012: Establishing a Fill and Finish Network HHS-BARDA-SSN-FFN_JAN12 ------------------------- 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 Department of Health & Human Services (HHS) has a future requirement to establish a Fill and Finish Network (FFN) to provide filling and finishing capabilities as core services for influenza vaccine product and other public health emergency biopharmaceutical products to address national security and to augment public health needs on a cost-effective, reliable, and sustainable basis. Core services may include, but are 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. The FFN will connect our industrial partners with needed technical and regulatory expertise including facilitating interactions with FDA's new regulatory science initiative. Establishing the FFN with multiple capabilities and differing manufacturing platforms will allow for maximum flexibility and adaptability to respond to changes in technology and/or disease threats. Anticipated minimum Mandatory Eligibility Criteria for this acquisition are: 1. U.S. based filling facility. 2. Has filled an FDA licensed biopharmaceutical in single or multi-dose vials within the last year. 3. Written evidence of a commitment to provide the additional capability to fill fifty (50) million doses of pandemic influenza vaccine in finished multi-dose vials, with internal testing completed within nine (9) weeks of availability of formulated material. This acquisition is intended to create the contractual, business and regulatory relationships between offerors and the organizations that hold the license to the pandemic influenza product(s) necessary to meet the stated HHS objective of having 600 million doses available in 6 months, post HHS declaration of a Public Health Emergency, in response to a pandemic. It is anticipated that the majority of the time leading up to the fill and finish of 600 million doses will be occupied by viral seed selection and preparation, vaccine bulk drug substance manufacture, reagent development and bulk product release. Nine weeks are anticipated to be required upon availability of formulated material for several offering organizations to respond in parallel to the filling of pandemic influenza vaccine in finished multi-dose vials with complete internal testing. In the case of a pandemic, these relationships are designed to provide the USG with access as the majority of U.S.-based filling. To accomplish this goal the USG seeks to create a robust network of fill and finish service providers that can be readily accessed in the event of a pandemic. During inter-pandemic periods, a warm-base effort will be executed with Fill and Finish Network members to ensure their capabilities are maintained in a state of readiness. Objective 1 (Base Period) Augment Current US-based Fill and Finish Capacity: The Offeror will enhance domestic biopharmaceutical filling and finishing capabilities for pandemic influenza vaccines and other public health emergency biopharmaceutical products at pilot and commercial scales. Offerors should provide a strategy to appropriately incorporate emerging and innovative technologies that could be applied to current or future USG MCM development efforts to reduce risk, increase yield, reduce total life cycle costs and/or increase throughput. Objective 2 (Option Period) Provide Filling and Finishing Core Services: Core services must provide technology transfer and fill and finish of influenza vaccine and other public health emergency biopharmaceutical products under development by the USG. Core services include the filling and finishing capability to produce clinical investigational lots, engineering lots, process validation lots, and commercial-scale lots. Core services may include, but are not limited to the following areas to support formulation, filling and finishing operations: technology transfer from 3rd party biopharmaceutical company(ies) analytical testing development, ), process optimization, process validation, labeling, packaging and distribution. Core services may be provided to support the filling and finishing of products including sterile injectable drug, biopharmaceuticals, monoclonal antibodies, recombinant proteins, antitoxins, bacterial or viral vector-based products, and attenuated/killed virus vaccines used to prevent and/or treat, but not limited to, pandemic influenza. These or other candidate products could be filled and finished using technology platforms including, but not limited to, powders, liquid or lyophilized vials, single dose or multi-dose, prefilled syringes or sprayers, single packed dose or multi-packed doses. Fill and Finish Network facilities may provide support capabilities, including but not limited to: Formulation, Analytical and Process Development, Program Management and Regulatory Affairs. Teaming arrangements will be considered. Objective 3 (Option Period) Provide Biopharmaceutical Fill and Finish Surge Capacity: Offerors will augment existing biopharmaceutical filling and finishing biopharmaceutical manufacturing capacity to create a U.S.-based surge capability that can be pre-positioned to respond to public health emergencies such as an influenza pandemic and other public health emergency. Offerors shall present a capability to fill fifty (50) million doses of pandemic influenza vaccine in finished multi-dose vials with internal testing completed within nine (9) weeks of availability of formulated material based on a USG task order. For the influenza vaccine product(s) proposed, Offerors shall present a technical transfer plan and sustainability plan that ensure the capability is pre-positioned throughout the period of performance of the contract. It is anticipated that a Request for Proposal (RFP) will be announced approximately late February/ early March 2012 with proposals due in April 2012. While the mandatory qualification criteria do not have to currently be met for response to this sources sought notice, all of the mandatory qualification criteria shall be met by proposal submission. It is requested that respondents to this sources sought notice may identify their interest by submitting the following information: 1. Rate capacity for multi-dose vials, single dose vials, syringes and sprayers is sought. 2. Ability to fulfill core services including but are 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. 3. Existing and potential relationships with influenza vaccine Phase 3 and FDA licensed bulk material producers allowing for filling and finishing of Phase 3 and FDA licensed bulk material in the respondent's facility. 4. Capabilities for non-influenza vaccine product fill and finish are also of interest in the context of public health emergency product fill and finishing. 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 -Fill and Finish Network-Jan 2012 and be submitted to Keith Johnson, Contract Specialist, at keith.johnson@hhs.gov and Kyle Roberts, Contracting Officer at kyle.roberts@hhs.gov by 2:00pm EST January 24, 2012. Contracting Office Address: Biomedical Advanced Research and Development Authority 330 Independence Avenue, SW, Room G640 Washington, District of Columbia, 20201 Primary Point of Contact: Mr. Kyle Roberts, Contracting Officer Kyle.roberts@hhs.gov Phone: 202-260-0747 Fax: 202-205-6061 Secondary Point of Contact: Mr. Keith Johnson, Contract Specialist Keith.Johnson@hhs.gov Phone: 202-260-8532 Fax: 202-205-6061