and Human Services (HHS)
SOURCES SOUGHT: OPERATION OF A VIRUS VACCINE PRODUCTION FACILITY Release Date: April 26, 2002 NOTICE: NOT-AI-02-021 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) Receipt Date: June 14, 2002 DESCRIPTION The Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, seeks Capability Statements from qualified sources to provide the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to prepare, with the approval of the Project Officer, suspensions of viruses which have been shown by evaluation in vitro and in vivo to be promising candidates for use in immunoprophylaxis of human diseases. Also prepare suspensions of wild type viruses, which are needed for evaluation of effectiveness of immunoprophylaxis. These virus suspensions, which are chosen for evaluation in volunteers by the Project Officer, shall be prepared using methods and in facilities which meet FDA standards for preparation of licensed live virus vaccines as described in the most current Code of Federal Regulations, specifically 21 CFR 58, 21 CFR 210, 21 CFR 211, 21 CFR 600, and 21 CFR 610. When applicable, animal derived raw materials and virus suspensions shall be tested for bovine and porcine viruses as described in 9 CFR 113.47 and 9 CFR 113.53. Virus suspensions shall be prepared by methods required by FDA for production of licensed live virus vaccines as described in the above referenced CFR. Further, these suspensions shall be safety-tested for absence of adventitious agents by procedures required for live virus vaccines licensed by the Center for Biologics Evaluation and Research (CBER), FDA, using the CFR sections indicated above as guidelines. In addition, the following guidelines should also be followed in the preparation of the live or the non-living viral vaccines or wild type viruses as needed: A. Points to Consider in the Characterization of Cell Lines to Produce Biologicals, CBER (7/93), at: http://www.fda.gov/cber/gdlns/ptccell.pdf B. ICH Harmonised Tripartite Guideline Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin: Federal Register, Vol 63, No.185 51074-51084 (9/24/1998). C. ICH Guideline Q5D: Derivation and Characterization of Cell Substrates Used for the Production of Biotechnological/Biological Products at http://www.ifpma.org/pdfifpma/q5d.pdf D. FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products, Federal Register, Vol 60 No.132,35750-35753 or http://www.fda.gov/cber/gdlns/pilot.txt E. Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description for a Vaccine or Related Product at http://www.fda.gov/cber/gdlns/cmcvacc.pdf F. Guidance for Industry: Good Manufacturing Practice Guidance Q7A: Good Manufacturing Guidance for Active Pharmaceutical Ingredients at http://www.fda.gov/cber/gdlns/ichactive.pdf G. Guidance for Industry: Manufacturing, Processing or Holding Active Pharmaceutical Ingredients http://www.fda.gov/cber/gdlns/active.pdf H. Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant Derived Product or a Monoclonal Antibody for in vivo use, http://www.fda.gov/cber/gdlns/cmcdna.pdf I. ICH Guideline Q5B (Genetic Stability): Quality of Biotechnology Products: Analysis of the Expression Construct in Cells used for the Production of r-DNA Derived Protein Products, at http://www.ifpma.org/pdfifpma/q5b.pdf J. ICH Final Guidelines on Stability Testing of Biotechnology/Biological Products, Federal Register, Vol. 61, No. 133 36466-36469, (7/10/1996). K. ICH Guideline Q6B: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, Federal Register, Vol 63, No. 110 31056-31513 (6/9/1998). L. ICH Guideline Q2A: Text on Validation of Analytical Procedures http://www.ifpma.org/pdfifpma/q2a.pdf M. ICH Guideline q2B: Validation of Analytical Procedures: Methodology, http://www.ifpma.org/pdfifpma/q2b.pdf N. Guidance for Industry: The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA- Regulated Products for Human Use at http://www.fda.gov/opacom/morechoices/industry/guidance/gelguide.htm Potential offerors shall be able to prepare the following virus suspensions and associated services as requested by the project Officer: 1. Paramyxoviruses. Prepare 1-2 liters of four (4) suspensions of wild type or attenuated parainfluenza or respiratory syncytial virus per year in (i) human or simian diploid cells such as FRhL cells or (ii) heteroploid cells such as Vero cells that have been qualified for use in the production of a live virus vaccine for administration to humans as currently recommended by the FDA. These viruses shall include human wild type, temperature sensitive (ts) and cold adapted (ca) viruses, and viruses derived using recombinant DNA technology. Produce and test these viruses as described above and ensure that they have an infectivity of 106 or greater for parainfluenza viruses and 105 or greater for respiratory syncytial virus. Vaccine candidates for the recently described human metapneumoviruses might also need to be made. 2. Rotavirus. Prepare 2-3 liters of three (3) rotavirus suspensions each year in cell cultures of primary or secondary African green monkey kidney (demonstrated previously to be free of simian adventitious agents) or in human or simian cells suitable for production of vaccines intended for use in humans. Aliquot virus suspensions which (a) have acceptable infectivity, i.e., 106 pfu per ml titered in MA104 cells or other suitable infectivity titers as determined by the Project Officer and (b) retain the identity of the rotavirus supplied by the Project Officer. 3. Hepatitis. Each year, distribute up to two (2) different suspensions of non-living hepatitis virus vaccine (eg., inactivated whole virus vaccine or virus like particles prepared by recombinant DNA technology) into vials and perform final container safety test for sterility and general animal safety. In addition, prepare 2-3 liters of two (2) virus suspensions of candidate live attenuated hepatitis virus vaccines per year. It may be necessary to clone and characterize selected tissue culture cells for their usefulness as substrates for hepatitis virus vaccine production. 4. Vaccinia Viruses. Prepare about 500 ml of 2 preparations per year of recombinant vaccinia virus, primarily a derivative of MVA (Modified Vaccinia Ankara), bearing an insert of a gene of interest to NIAID scientists (e.g., the G and F glycoproteins of respiratory syncytial virus or the E protein of dengue virus) for studies in humans. Produce such candidate virus vaccines in cells derived from avian species suitable for use in preparation of viruses destined for use in humans. Ensure that each preparation has a virus titer of approximately 108.5-9.0 pfu/ml. 5. Dengue viruses. Prepare 2-3 liters of three (3) wild type or live attenuated dengue virus per year in Vero or other cells qualified for use in preparing vaccines for administration to humans. Viruses will be supplied by the Project Officer in the form of DNA-derived viruses recovered from transfected C6/36 mosquito cells or Vero cells. The viruses will be amplified and cloned in Vero or another cell line qualified for use in the preparation of viruses to be given to humans. Ensure that the viral preparations have an infectivity of 105.0-6.0 or greater. The viruses are to be administered parenterally and should contain no serum or antibiotics. The amount and size of cell DNA that contaminates the vaccine should meet FDA requirements for parenterally administered vaccine preparations prepared in cell lines such as Vero cells. 6. Caliciviruses. Prepare two (2) suspensions of recombinant virus-like particles (VLPs) per year for calicivirus reference strains of interest. The VLPs will be purified from the culture fluids of insect cells infected with recombinant baculoviruses expressing the capsid protein of human calicivirus strains such as the Hawaii, Toronto, and Desert Shield viruses. Approximately 50 mg of purified VLP protein for each virus strain will be needed for use in diagnostic assays. Safety testing of these diagnostic reagents will not be required. In addition, VLPs will be purified for evaluation as vaccine candidates. Approximately two (2) preparations of 10-30 mg of VLP for administration to humans will be made per year. Prepare one (1) challenge virus suspension per year derived from a stool filtrate according to tests required by FDA for biological materials suitable for administration to humans. 7. Influenza Viruses. Prepare (2) virus suspension of 2-3 liters of influenza virus in embryonated chicken eggs obtained from specific pathogen free flocks and safety test these suspensions during each contract year. These viruses include wild type and attenuated influenza virus of H1N1 and H3N2 subtypes or other subtypes as they appear in nature. Seed virus will be provided by the Project Officer. The suspensions shall be grown in SPAFAS avian leucosis virus-free embryonated eggs. The final product shall be tested for freedom from avian leucosis virus and other adventitious microbial agents. The viral suspensions shall (a) have requisite infectivity, i.e., 107.5 to 108.0 plaque forming units (pfu) per ml measured on MDCK cell culture monolayers in the presence of ~1 g of trypsin per ml and (b) retain the laboratory markers of the attenuated seed virus such as high efficiency of plaque formation at low temperature (ca phenotype) or decreased efficiency of plaque formation at high temperature (ts phenotype). 8. Provide documentation for all animal derived raw materials used in the manufacture of these virus suspensions including country of origin and certificates of analysis documenting the quality control tests performed by the vendor. 9. Store the virus suspensions at -70 C or below and distribute aliquots to laboratory of clinical investigators at the direction of the Project Officer. 10. Provide detailed protocols for those virus suspensions which meet FDA requirements for preparation of seed virus, for growth of virus suspension, and for demonstration of freedom of the virus suspension from adventitious agents. These preparations will include, but not be limited to, the following viruses. The ability to prepare viruses using BSL3 conditions might be needed in rare situations. 11. Deliver the materials, i.e., viruses and appropriate Clinical Lot Release Protocols within five (5) months of the date of availability of seed viruses in order to accomplish the goals of this contract. 12. Provide a repository for the long-term storage of government-owned viruses at 75 C for viruses and and cells banks 150 C for the cell lines. 13. Produce and qualify cell lines as directed by the Project Officer for use by LID and by the contractor in the production of viruses to be administered to humans or for other uses as directed by the Project Officer. Cell lines produced and qualified for use under this contract will be considered government-owned materials. Any potential offeror must be able to document the experience and capabilities of professional and technical personnel assigned to this project. The professional and technical personnel shall have extensive experience in the preparation of suspension of viruses, including wild type viruses. In addition, the offeror must possess the necessary facilities to accomplish this work, or must demonstrate the ability to obtain these. Capability statements may be submitted to the following address: Contracting Officer Acquisition Management and Operations Branch National Institutes of Allergy and Infectious Diseases National Institutes of Health 6700-B Rockledge Drive Room 1127, MSC 7605 Bethesda, MD, 20892-7605 Point of Contact: Ivan Hernandez, Contract Specialist, Phone 301-496-3878 John Foley, Contracting Officer, Phone 301-496-3878 This announcement does not commit the Government to award a contract. No collect calls will be accepted.
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