SOURCES SOUGHT
B -- RFI: Acquisition of MCMs for Pandemic Influenza Preparedness and Response
- Notice Date
- 9/21/2011
- Notice Type
- Sources Sought
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Acquisitions Management, Contracts, & Grants (AMCG), Office of the Assistant Secretary for Preparedness & Response (ASPR), Department of Health and Human Services, 330 Independence Ave. SW, G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- 11-100-RFI-00020
- Point of Contact
- Thomas P. Hastings-Tickerhoff, Phone: 202-720-2823, RoseMary T Mann, Phone: 202-260-1572
- E-Mail Address
-
thomas.hastings-tickerhoff@hhs.gov, rosemary.mann@hhs.gov
(thomas.hastings-tickerhoff@hhs.gov, rosemary.mann@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- SCOPE AND REQUIREMENTS This program builds on investments made by HHS/BARDA to fulfill its mission to provide MCMs for pandemic influenza threat or other public health emergencies. Previous investments (2004-2009) have included the acquisition of pre-pandemic influenza vaccine and adjuvants for stockpiling. The objective of this new requirement is to have contracts with manufacturers who are able to produce influenza vaccines (inactivated, live attenuated, recombinant, egg-based, cell-based) from pre-pandemic and pandemic viruses or other public health emergency vaccines or biological products (bulk and /or fill-finish products). Contractors must be able to produce influenza vaccine at commercial scale and hold a documented US licensure OR have developed a seasonal influenza vaccine, completed Phase 3 clinical studies with a documented BLA in preparation. Contractors also must be able to produce other vaccines or biological products in the event of a public health emergency. The contractors shall provide the following: • Master and working virus seed for production of influenza pre-pandemic and pandemic vaccine product. • Influenza pre-pandemic and pandemic vaccine production at small scale, clinical and commercial scale. • Production of vaccines or biological products (bulk product) using the Contractor's resident facilities and technologies in a public health emergency as determined by HHS. • Adjuvant production at commercial scale. • Vaccine and adjuvant storage and stability studies. • Formulation and fill-finish manufacturing of pre-pandemic, pandemic influenza vaccine and adjuvant. • International shipping of vaccine. • Disposal of vaccine bulk and final container • Non-clinical and clinical studies using pre-pandemic and pandemic influenza vaccine. • Storage services and stability program for vaccine and adjuvants, (bulk and final containers) from current expiring contracts, when applicable. • Production, formulation and fill-finish manufacturing of vaccines or biological products in the event of a public health emergency as determined by HHS. NOTE 1 Contractors holding a US license for an influenza vaccine shall perform all activities described in the CLINs according to those of their FDA-licensed influenza vaccine product process, including but not limited to the same facilities, systems, equipment, processes and testing as for the licensed product. In lieu of a licensed process, Contractors with unlicensed influenza vaccine products that have completed the final clinical study report for their Phase 3 trial and are preparing the BLA shall perform all activities described in the following CLINs using the same facilities, systems, equipment, processes, and testing as those described in the BLA document in preparation. Only Contractors without a licensed influenza vaccine may use unlicensed processes to perform the following CLINs. Contractors that receive licensure during the course of this contract are required to use the licensed process for the duration of the contract. DESCRIPTION CLIN 0001: cGMP Influenza Vaccine Master and Working Seed Lot Under Item 0001, the Contractor shall provide master and working seed lots for inactivated, live attenuated or recombinant influenza vaccine product. The seeds lots for influenza vaccine product shall be manufactured using the same facilities, systems, equipment, processes and testing as those used for the FDA-licensed influenza vaccine or as described in the BLA in preparation. The influenza vaccine seed lot shall be produced using a qualified virus reference strain as designated by HHS. The Contractor shall, as specified in the note above: • Manufacture the seed lot from the influenza virus vaccine candidate specified by HHS. Manufacture the seed lot at commercial scale in commercial manufacturing facilities described and referenced for this activity in the FDA license or in-process BLA according to current Good Manufacturing Practices (cGMP) under 21 CFR parts 210, 211, and 600, as applicable, and store at appropriate conditions during lot release testing. • Use a validated, commercial-scale production process for influenza vaccine to manufacture the seed lots. Where applicable use processes detailed in the licensed vaccine manufacture. For un-licensed vaccine products, use processes described in the in-process BLA. • Provide lot release product testing of the influenza seed lot (using lot release specifications similar to those of the FDA-licensed influenza product, or the in-process BLA filing). Submit seed samples to the FDA for testing and approval for use in vaccine production. • Store seed lots according to FDA cGMP guidelines. CLIN 0002: Non-GMP Influenza Vaccine: Pilot Lot(s) Under Item 0002, the Contractor shall provide an influenza vaccine non GMP pilot lot. The Contractor shall: • Provide all data derived from process yield improvement efforts. • Make available batch records for review by HHS • Provide Certificates of Analysis for the manufactured lot. • Execute a stability program for sixty (60) months. Stability testing shall be performed applying FDA cGMP guidelines. Provide the study plan, interim results and final report to HHS. CLIN 0003: cGMP Influenza Vaccine: Bulk Clinical Lot (s) Under Item 0003, the Contractor shall provide influenza vaccine clinical lot. The investigational clinical lot will be manufactured, as applicable and specified in NOTE 1 above. The Contractor shall: • Manufacture the clinical vaccine lot in manufacturing facilities according to current Good Manufacturing Practices (cGMP) under 21 CFR parts 210, 211, and 600. • Use a validated and licensed, or BLA document in preparation, production methods for influenza vaccine manufacture. • Perform lot release product testing of the influenza vaccine including potency using lot release specifications similar to those of the FDA-licensed influenza vaccine product or described in the BLA document in preparation. Provide results to HHS. • Make batch records available for review by HHS. • Provide Certificates of Analysis for the manufactured clinical lots to HHS. • Provide a master stability program for sixty (60) months to HHS. Stability testing shall be performed applying FDA cGMP guidelines and in accordance with the stability requirements that apply to FDA-licensed trivalent influenza vaccine product, if applicable. • Execute a master stability program for sixty (60) months and provide interim and final results to HHS. CLIN 0004: cGMP Influenza Vaccine: Bulk Lot(s) Under Item 0004, the Contractor shall provide influenza vaccine bulk product from viruses with pre-pandemic and pandemic potential suitable for formulation and filling. The unit for this item will be manufacturing of bulk lot(s) influenza vaccine product. The size of a lot will be defined by the manufacturers (number of eggs, bioreactor size in liters, etcetera) as described in their proposal and accepted by the HHS. The bulk lot of influenza vaccine shall be manufactured, if applicable, using the same facilities, systems, equipment, processes and testing as those used for the FDA-licensed influenza vaccine or the in-process BLA. The influenza vaccine shall be produced using a qualified virus reference strain designated by HHS. The Contractor shall: • Manufacture the bulk vaccine product at commercial scale in (FDA-licensed or in-process BLA documented) manufacturing facilities, when such production does not interfere with inter-pandemic influenza vaccine manufacturing, or when required by HHS. • Manufacture the bulk vaccine product according to current Good Manufacturing Practices (cGMP) under 21 CFR parts 210, 211, and 600, as applicable, and store at appropriate conditions during lot release testing and prior to formulation. • Use a validated and licensed (or in-process BLA documented) commercial-scale production process for influenza vaccine to manufacture monovalent influenza bulk vaccine. • Conduct lot release product testing of the influenza bulk vaccine. Provide results to HHS. • Make batch records available for review by HHS. • Provide Certificates of Analysis for the manufactured lots to HHS. • Provide a master stability program for sixty (60) months to HHS. • Execute stability testing of vaccine complying with FDA cGMP guidelines and in accordance with the stability requirements that apply to FDA-licensed influenza vaccine product, if applicable. Report interim data and results to HHS. CLIN 0005: cGMP Adjuvant: Bulk Lot(s) Under Item 0005, the Contractor shall provide an adjuvant bulk product suitable for formulation and filling. The unit for this item will be manufacturing of one lot of adjuvant bulk product. The size of a lot will be defined by the manufacturers (lot size in e.g. liters) as described in their proposal and accepted by the HHS. The Contractor shall: • Manufacture the bulk adjuvant product at commercial scale according to current Good Manufacturing Practices (cGMP) under 21 CFR parts 210, 211, and 600, as applicable, and store at appropriate conditions during lot release testing. • Execute lot release product testing of bulk adjuvant. Provide final report to HHS. • Make available batch records for review by HHS. • Provide Certificates of Analysis for the manufactured lots to HHS. • Provide a master stability program for sixty (60) months to HHS. • Execute stability testing of adjuvant compliant FDA cGMP guidelines. Report interim data and results to HHS. CLIN 0006: Storage of Bulk Lot(s) of Vaccine and/or Adjuvant Under Item 0006, the Contractor shall provide temperature controlled storage for all manufactured lots for sixty (60) months at the Contractor site or at a designated facility approved by HHS. The Contractor shall perform storage using cGMP facilities. The unit for this item will be storage of lot(s) of vaccine or adjuvant product / month. The Contractor shall: • Store vaccine and adjuvant lots in (FDA-licensed) storage facilities. Storage shall be physically segregated from other products and product will be identified as USG property. • Store vaccine and adjuvant at the Contractor site or at a designated facility approved by HHS applying FDA cGMP guidelines and in accordance with the storage requirements that apply to FDA-licensed influenza vaccine product, if applicable. • The government reserves the right to review the security system in place and request updates as needed. CLIN 0007: Extended Storage of Bulk Lot(s) of Vaccine and/or Adjuvant Under Item 0007, the Contractor shall extend the storage as described in CLIN 006 for all manufactured lots for six (6) months at the Contractor site or at a designated facility approved by HHS. CLIN 0008: Storage of Bulk Lots of Vaccine and/or Adjuvant from Prior Contracts Under Item 0008, The Contractor shall provide temperature controlled storage for sixty (60) months at the Contractor site or at a designated facility approved by HHS. The Contractor shall perform storage using the cGMP facilities, systems, equipment, and processes, as those used for the product release for FDA-licensed influenza vaccine or in-process BLA documented procedures, as applicable. Contractors who are currently storing pre-pandemic influenza bulk vaccine and bulk adjuvant under previous contracts shall transfer storage of those products to the present Item (CLIN 0008) at the expiration of previous contracts. The unit for this item will be storage of lot(s) of vaccine or adjuvant product / month. The Contractor shall: • Store vaccine and/or adjuvant lots in FDA-licensed storage facilities. Storage shall be physically segregated from other products. • Store vaccine and adjuvant at the Contractor site or at a designated facility approved by HHS complying with FDA cGMP guidelines and in accordance with the storage requirements that apply to FDA-licensed influenza vaccine product. • Continue stability testing of stored bulk for sixty (60) months • The government reserves the right to review the security system in place and request updates as needed. CLINs 0009-0013: Formulation and Filling of Influenza Vaccine and/or Adjuvant in a Variety of Final Containers. When executing CLINS 0009-0013, the contractor shall: • Perform formulation and filling activities in compliance with FDA cGMP guidelines and license (or in-process BLA documentation). • Affix labels onto filled final containers with FDA-approved text for a similar product such as licensed influenza vaccine. HHS may require coding on primary containers and secondary packages for product identification, serialization, lot number and expiration dating in accordance with FDA and GS1 / ISO standards. • Package filled and labeled final containers into FDA approvable containers. • Execute lot release product testing of the influenza vaccine final container using lot release specifications similar to those of the FDA-license influenza vaccine product. Provide a final report to HHS. CLIN 0009: Formulation of vaccine at the approved concentration and at a dosage designated by the HHS. Fill single dose vials with formulated vaccine product at the volume designated by the HHS. Note the additional requirements of CLINs 0009-0013 above. CLIN 00010: Formulation of vaccine at the approved concentration and at a dosage designated by the HHS. Fill syringes or sprayers with formulated vaccine product at the volume designated by the HHS. Note the additional requirements of CLINs 0009 -0013 above. CLIN 0011: Formulation of vaccine at the approved concentration and at a dosage designated by the HHS. Fill multi-dose vials with formulated vaccine product at a volume to be designated by HHS. Note the additional requirements of CLINs 0009 -0013 above. CLIN 0012: Formulation of vaccine and adjuvant at the approved concentration and at a dosage designated by HHS. Fill syringes with formulated adjuvanted vaccine product with a volume to be designated by HHS. Note the additional requirements of CLINs 0009-0013 above. CLIN 0013: Formulation of vaccine and adjuvant at the approved concentration and at a dosage to be determined by the US Government. Fill multi-dose vials with formulated adjuvanted vaccine product at a volume designated by HHS. Note the additional requirements of CLINs 0009-0013 above. CLIN 0014: Storage and Stability in Final Containers of CLINS 0009-0013. Under Item 0014, the Contractor shall provide temperature controlled storage and stability program for final containers (CLINs 0009, 0010, 0011, 0012 and 0013) for thirty-six (36) months at the Contractor site or at a designated facility approved by HHS. The Contractor shall perform storage using the cGMP facilities, systems, equipment, and processes, as those used for the product release for FDA-licensed influenza vaccine. The Contractor shall: • Store the final containers in an FDA approved storage facilities. Storage shall be physically segregated from other products. • Store final containers up to thirty six (36) months at the Contractor site or at a designated facility approved by HHS applying FDA cGMP guidelines and in accordance with the storage requirements that apply to FDA-licensed influenza vaccine product. • The government reserves the right to review the security system in place and request updates as needed. • The contractor shall define storage density for each product and provide details to HHS for concurrence. Execute stability testing of final containers under this program. Stability testing shall be performed applying FDA cGMP guidelines and in accordance with the stability requirements that apply to ICH guidelines / FDA-licensed influenza vaccine product. CLIN 0015: Extended Storage and Stability of CLINS 0009-0013 Under Item 0015, the Contractor shall extend storage and stability program as described in CLINs 14 for final containers (CLINs 0009, 0010, 0011, 0012 and 0013) for six (6) months. CLIN 0016: International Shipping of CLINS 0009-0013 Under CLIN 0016, the Contractor will transport final containers under CLINs 0009-0013 to countries designated by HHS. The Contractor shall: • Package, store, handle and ship CLINs 0009-0013 from their site or temporary storage site to a final destination. • Include all cost and expenses for transit, delivery and insurance of product. • Be responsible for delivering material in a condition fit for its intended use. • As noted above, for products produced internationally all costs of importation into the US are to be borne by the Contractor. CLIN 0017: Disposal Under CLIN 17, the Contractor will dispose of all products from CLINs 0001-0005 and CLINs 0009-0013 if required by the USG. The Contractor shall: Dispose of product following any federal, state regulation for the appropriate waste category; hazardous waste (thimerosal-containing vaccines), regulated medical waste (LAIV), solid waste (non thimerosal-containing vaccine, non LAIV). CLIN 0018: Influenza Vaccine Murine Immunogenicity Test Under Item 0018, the Contractor shall perform murine immunogenicity studies using the vaccine: • Influenza vaccine or filled vaccine stored can be used for animal studies to monitor vaccine safety and stability. • Protocol will be provided by HHS and the study to be conducted by the Contractor will involve the use of 80 mice, divided in 4 groups. Each group will receive vaccine at different dosage and control groups will be included. CLIN 0019: Influenza Vaccine Clinical Immunogenicity Test Under Item 0019, the Contractor shall perform clinical studies to assess and monitor immunogenicity of the stored vaccine: • Bulk vaccine or filled vaccine stored can be used for clinical studies. • Protocol will be provided by HHS and the study to be conducted by the Contractor or subcontractor will involve the use of 50-500 subjects, receiving one or two doses of vaccine at concentration to be determined by HHS or placebo. CLIN 0020: Additional Reporting and Inventory Requirements Under Item 0020, the Contractor shall submit inventory reports, monthly progress reports, executive summaries, ad hoc reports of urgent developments related to this program and a final report as described in detail in the Reporting requirements and Deliverables. Release protocols and reports shall be also provided to HHS after each manufacturing campaign. NON-INFLUENZA CLINs: These CLINs (0021 AND 0022) provide the USG with the option to conduct non-influenza manufacturing activities utilizing the large-scale influenza vaccine and adjuvant facilities, equipment and personnel in the event of a public health emergency. Responses to these CLIN are required. Responses will be evaluated separately from other CLIN responses. CLIN 0021: Production of other vaccines or biological products licensed by the Contractor in a public health emergency as determined by HHS. • Production of vaccine or biological bulk product according to the approved BLA or in-process BLA. • Formulation of bulk product according to processes described in the BLA or in-process BLA. CLIN 0022: Fill-finish of other vaccines or sterile injectable products in the event of a public health emergency as determined by HHS. • Technology transfer filling processes to in-house. • Fill-finish activities of sterile injectable products in compliance with FDA cGMP guidelines. • Affix labels onto filled final containers with FDA-approved text for a similar product. HHS may require coding on primary containers and secondary packages for product identification, serialization, lot number and expiration dating in accordance with FDA and GS1 / ISO standards. • Package filled and labeled final containers into FDA approvable containers. • Execute limited lot release product testing of the final container. Provide a final report to HHS. • Ship material samples to license holder. RFI Response Organizations with the capabilities to provide the requirements of the Statement of Work are invited to submit statements to HHS. Data obtained from this RFI will be used by HHS in making recommendations and decisions on the development of an appropriate planning and procurement strategy. All information will be kept confidential as allowed by relevant Federal law and will be eligible for additional special protections under the conditions of the Protected Critical Infrastructure Information (PCII) Program outlined in the Critical Infrastructure Information Act of 2002. Information must be submitted by 3:00pm (EST) on October 5, 2011. Include the name, email address and telephone number of a primary contact point in your organization for this RFI in the event that HHS has additional questions or requires clarification on the submitted information. Responses are limited to 15 pages, including appendices and attachments. Respondents shall submit all documents electronically in.pdf format to thomas.hastings-tickerhoff@hhs.gov. The type of business submitting the response (i.e. small business, large business, hub-zone, small and disadvantaged business, etc.) shall be identified in your response.
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