Fill and Finish Manufacturing Network
Added: Jan 23, 2013 3:19 pm
THIS IS A FORMAL SYNOPSIS OF A PROPOSED CONTRACT ACTION NOTICE IN ACCORDANCE WITH FAR 5.2. THIS COMPETITIVE ACTION IS BEING PROCURED UNDER FULL AND OPEN COMPETITION.The United States Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) seek to establish a Fill and Finish Manufacturing Network (FFMN) that facilitates medical countermeasure (MCM) and ensures domestic pharmaceutical1 surge fill and finish capacity. These fill and finish U.S. based Facilities are expected to provide filling and finishing capabilities for influenza vaccines and other public health emergency products to address national security and to augment public health needs on a cost- effective, reliable, and sustainable basis. HHS/BARDA requires the services of Contractor(s) to provide filling and finishing services to other commercial partners under contract to the U.S. Government (USG) for filling and finishing of influenza vaccines and possibly for pharmaceuticals against CBRN threats or to support fill finishing for other drug shortages. The work performed at the FFMN will be coordinated and integrated by HHS/BARDA with programs from other USG agencies to provide long-term solutions that address the medical consequences of currently known and unknown threats. Members of the U.S.-based FFMN are expected to provide fill and finish capabilities for pandemic influenza vaccines to address national security and to augment public health needs on a cost-effective, reliable, and sustainable basis.This acquisition is intended to create the necessary contractual, business and regulatory relationships between the USG, Offerors and the organizations that hold the license for pandemic influenza product(s) to meet the stated HHS objective of having 600 million doses of pandemic influenza vaccine 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 to 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 readily be accessed in the event of a pandemic. During non-pandemic periods, a warm-base effort may be executed with Fill and Finish Network members to ensure their capabilities are maintained in a state of readiness.Minimum Mandatory Eligibility Criteria:1. U.S.-based filling facility: The Offeror shall demonstrate written evidence that the Offeror has unencumbered access to a US based filling facility which will be proposed for this solicitation and will be used for the duration of the contract.2. Written evidence the Offeror has filled an FDA licensed/approved sterile product within the last two (2) years: Written evidence the Offeror shall have proficiency in filling and finishing pharmaceutical products in single and multi-dose packaging. This shall be demonstrated by the Offeror having filled a FDA licensed/approved sterile product within the last two (2) years at the facility being proposed; or a Bulk Influenza vaccine manufacturer who has manufactured an FDA licensed influenza vaccine, and has a partnership with a company/contractor who has filled an FDA licensed/approved sterile product within the last two (2) years in their US-based facility which is being proposed for this solicitation (provide written evidence).3. Written capability statement for pandemic influenza vaccine production. The statement describes the current capacity and proposed additional capacity anticipated to be augmented, including additional resources if needed, as part of this solicitation. The statement shall include number of doses (10-dose multi-dose vials), time frame required, and level of effort (additional resources) required to fulfill the additional doses. For the purposes of this solicitation, the maximum time frame to provide released doses is 12 weeks.The initial work during the contract will be the technology transfer and may include modifications, if necessary, of existing equipment within pharmaceutical fill and finish facilities to meet FDA and cGMP standards for clinical, and Phase 3 Clinical, Commercial-scale fill and finish needs of the USG. All facilities established under the FFMN shall ensure the ability to provide, on an emergency basis, the agreed upon number of doses of pandemic influenza vaccines in finished multi-dose vials with complete internal testing within12-weeks. The technology transfer process should also include support to the vaccine owner for submitting a license amendment for this new alternate fill/finish site.Once work within the facilities are completed and validated, the USG may issue task/delivery orders to maintain or utilize the FFMN for its intended purpose. The ability of the USG to solicit these services via a Task/ Delivery Order will be predicated by the Contractor's timing to bring those specific aspects of their fill and finish facility online. The following elements shall be included in an Offeror's SOW:Objective 1Augment Current US-based Fill and Finish Capacity:The Offeror shall expand domestic pharmaceutical filling and finishing capacity for advanced development influenza vaccines and other public health emergency products at pilot and commercial scale. The technology transfer and licensure amendment of such a pandemic influenza vaccine shall be executed as part of this objective. Fulfillment of this objective may include purchasing of change parts, additional equipment, and minor renovations to supplement and re-qualify an existing fill finish facility. Examples of acceptable activities may include upgrading and re-qualifying a previously obsolete filling line, replacing equipment such as a 5-head filler with a 10-head filler in order to increase throughput, adding automated inspection to replace a manual inspection process, and purchase of spare parts or dedicated parts in order to reduce changeover time between products. Construction of a new facility, retro-fitting of a current facility or facility addition is not within scope of this objective.The Offeror may pursue their own relationship to identify an FDA licensed or Phase 3 influenza vaccine candidate for use in their facility. Preference will be given to Contractors who are in an established BLA for influenza vaccines or partnering with a vaccine candidate that is at least at the Phase 3 stage. If the contractor does not secure such a candidate, the USG may introduce a pandemic influenza candidate(s) to the Offeror and encourage an agreement between a pandemic influenza vaccine candidate and the Offeror to meet this Objective. Future task Order Requests (TOR) may require establishment of new partnerships.Objective 2Provide Fill and Finish Services (Non-surge):Offerors shall provide fill and finish services 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, analytical testing, process optimization, process validation, formulation, filling, labeling and packaging, and distribution.Services may be provided to support the fill and finish of pharmaceuticals including parenteral drug products, monoclonal antibodies, recombinant proteins, antitoxins, bacterial or viral vector-based products, and attenuated/killed virus vaccines. As per the USG requirement, these liquid, lyophilized, or powder drug products may be filled and finished as prefilled syringes or sprayers, single dose or multi-dose vials.The funding for these future task orders is separate from the funding being allocated to create this Fill Finish Manufacturing Network. As the task orders are product specific, the separate funding for the future task orders may include materials, spare parts, equipment, staffing, fees, etc. that are within the task order scope and necessary to complete the required task.Objective 3Provide Fill and Finish Surge Capacity:Offerors shall have augmented the existing vaccine fill and finish infrastructure surge capacity for pandemic influenza, emerging infectious disease, and other threats of known and unknown origin during a public health emergency, as described in Objective 1. Once a public health emergency has been declared, the Offerors shall formulate, fill and finish bulk lots of pandemic influenza vaccine provided by the USG within 12 weeks in 10- dose multi-dose (5 ml or 10 ml) vials based on a USG task order. The government estimates the FFMN contractors will be given approximately 3 months notification that bulk pandemic influenza vaccine will need to be formulated and filled at the contractors' site. This estimate is dependent upon the bulk manufacturing and potency assay/calculations which are needed before formulation and filling can occur.Additionally, the USG anticipates that there may be other life saving products being produced for commercial needs at the selected contractor facilities. The delivery schedule for pandemic influenza vaccine 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.Offerors will be required to submit a detailed Statement of Work to address the objectives as part of their submission.It is anticipated that one (1) pre-proposal conference will be held during the solicitation period. Potential Offerors and any subcontractors are encouraged to attend. HHS/BARDA will be hosting a pre-proposal conference whose date and other public information will be posted on www.medicalcountermeasures.gov and www.fbo.gov in the Request for Proposals.Multiple contracts may be awarded as a result of this RFP. Contract(s) awarded under this solicitation are anticipated to be IDIQ type with a 10 year period of performance. Small Businesses interested in a teaming or partnering arrangement are highly encouraged to contact Offerors identified on http://www.FedBizOpps.gov for subcontracting opportunities.It is anticipated that a Request for Proposals to Establish a Fill and Finish Manufacturing Network will be issued 15 to 30 days after the release of this synopsis. The solicitation, all related documents and amendments, if any, will only be released and available electronically through the FedBizOpps. As such, no written, telephonic, facsimile or email requests for the solicitation package will be honored. Interested parties can register at the aforementioned site to receive procurement announcements by email. It is solely the responsibility of interested parties to monitor www.fbo.gov for any solicitation amendments.Any comments to this synopsis shall reference 13-100-SOL-00004 and be submitted to Quintin Hackshaw, Contract Specialist, at quintin.hackshaw@hhs.gov and Kyle Roberts, Contracting Officer at kyle.roberts@hhs.gov. Contracting Office Address:Acquisition Management Contracts and Grants330 Independence Avenue, SW, Room G640Washington, District of Columbia, 20201Primary Point of Contact: Mr. Quintin Hackshaw,Contract Specialist quintin.hackshaw@hhs.gov Phone: 202-260-0453Fax: 202-205-6061Secondary Point of Contact: Mr. Kyle Roberts, Contracting Officer kyle.roberts@hhs.gov Phone: 202-260-0747Fax: 202-205-6061This notice does not commit the USG to the award of a contract(s).
BARDA-13-100-SOL-00004 Department of Health and Human Services Immediate Office of the Secretary
1/23/13, 3:19 PM