SOLICITATION NOTICE
R -- Operation of a Virus Vaccine Production Facility
- Notice Date
- 11/29/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive MSC 4811 Room 2NE70-A, Bethesda, MD, 20817
- ZIP Code
- 20817
- Solicitation Number
- RFP-NIAID-DIR-03-51
- Archive Date
- 12/31/2002
- Point of Contact
- Ivan Hernandez, Contract Specialist, Phone 301-402-6954, Fax 301-480-0689, - John Foley, Contracting Officer, Phone 301-402-2284, Fax 301-480-0689,
- E-Mail Address
-
ihernandez@niaid.nih.gov, jfoley@NIAID.NIH.GOV
- Description
- The Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, has a requirement for services from a qualified source to provide the necessary personnel, material, equipment, and facilities not otherwise provided by the Government, to: A. Prepare, at the request of the Project Officer, suspensions of viruses that 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 that are needed for evaluation of effectiveness of immunoprophylaxis. These virus suspensions, which are intended 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 21CFR58; 21CFR210; 21CFR211; 21CFR600, and 21CFR610 (See http://www.gpo.gov/nara/cfr/index.html). When applicable, animal derived raw materials and virus suspensions shall be tested for bovine and porcine viruses as described in 9CFR113.46, 9CFR113.47, and 9CFR113.53. 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 to determine freedom from 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), @http://www.fda.gov/cber/gdlns/ptccelllines.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) or @http://www.fda.gov/cber/gdlns/virsaf.pdf c. ICH Guideline Q5D: Derivation and Characterization of Cell Substrates Used for the Production of Biotechnological/Biological Products @http://www.ifpma.org/pdfifpma/q5d.pdf d. Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description for a Vaccine or Related Product @http://www.fda.gov/cber/gdlns/cmcvacc.pdf e. ICH Final Guidelines on Stability Testing of Biotechnology/Biological Products, Federal Register, Vol. 61, No. 133 36466-36469, (7/10/1996) or @www.fda.gov/cber/gdlns/ich5c071096.pdf f. ICH Guideline Q6B: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, Federal Register, Vol 63, No. 110 31056-31513 (6/9/1998) or @http://www.fda.gov/cber/gdlns/biotest.pdf g. Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeld-Jakob Disease (CJD) and Variant Creutzfeld-Jakob Disease (vCJD) by Blood and Blood Products. @ http://www.fda.gov/cber/gdlns/cjdvcjd.pdf h. 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. B. Store the virus suspensions at -70 degrees C or below and distribute virus to third parties only at the direction of the Project Officer. C. Prepare virus suspensions that meet FDA requirements. The preparation of the viruses can in most cases be performed at BSL2 level, but the ability to prepare viruses at BSL3 conditions might be anticipated. These preparations will include, but not be limited to, the following viruses: 1-Paramyxoviruses. Prepare 1-2 liters of up to four (4) suspensions of wild type or attenuated parainfluenza, respiratory syncytial virus, or metapneumovirus per year in (i) human or simian diploid cells such as DBS-FRhL-2 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 wild type or attenuated viruses such as temperature sensitive (ts) and cold adapted (ca) viruses. The vast majority of the seed viruses provided to the contractor will have been produced at LID/NIH 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 or metapneumoviruses. Nucleotide sequence analysis and testing to determine if the candidate vaccines retain the laboratory markers of attenuation will be performed by LID/NIAID. 2-Rotavirus. Prepare 2-3 liters of up to three (3) rotavirus suspensions in human or simian cells such as DBS-FRhL-2 and Vero 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-Dengue viruses and other flaviviruses. Prepare 2-3 liters of up to four (4) wild type or live attenuated dengue virus per year in Vero or other cells qualified for use in preparing vaccines for administration to humans. Similarly prepare up to three (3) live attenuated vaccines for the following flaviviruses: tick-borne encephalitis virus, West Nile virus, and St. Louis encephalitis virus. 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 passaged and produced 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 not contain serum or antibiotics. Crude cell harvests containing virus can be treated with Benzonase to decrease the quantity and size of contaminating Vero cell DNA. The amount of cell DNA that contaminates the vaccine should meet FDA requirements for parenterally administered vaccine preparations prepared in cell lines such as Vero cells. Benzonase should not be detectable in the vaccine preparation administered to humans. Tests to estimate the size of DNA after Benzonase treatment, if sufficient DNA is present in the speciman, likely will be required by FDA for continued use of candidate vaccines through Phase II and III clinical trials. Nucleotide sequence analysis and testing to determine if the candidate vaccines retain the laboratory markers of attenuation will be performed by LID/NIAID. 4-Influenza Viruses. Prepare up to three (3) virus suspensions 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 attenuated influenza influenza A viruses belonging to hemagglutinin subtypes H1 to H15 and neuraminidase subtypes N1-N9 or to 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., 107.3 to 108.0 plaque forming units (pfu) per ml measured on MDCK cell culture monolayers in the presence of approximately one microgram 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). Laboratory workers who handle these viruses should be immunized with currently licensed influenza A virus vaccines. Nucleotide sequence analysis and testing to determine if the candidate vaccines retain the laboratory markers of attenuation will be performed by LID/NIAID. D. Deliver the materials, i.e., viruses and appropriate Clinical Lot Release Reports within five (5) months of the date of availability of seed viruses in order to accomplish the goals of this contract. The release reports for these virus suspensions will provide details of production of the virus suspension, the identity and titer of the virus using information provided by LID/NIAID on nucleotide sequence analysis (and other virus specific tests), demonstration of freedom of the virus suspension from adventitious agents, and quantity and size of Vero cell DNA, if sufficient DNA remains in the preparation for such characterization. E. Provide a repository for the GMP long-term storage of viruses at minus 75 degrees C for viruses produced by the contractor and of government owned cells banks at minus 150 degrees C. F. 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. As for all virus suspensions produced by the contractor, cell lines produced and qualified for use under this contract will be considered government-owned materials. It is estimated that an average of seven virus suspensions and one cell line will be produced and delivered annually. The lots that will be made are predominantly for Phase I/early Phase II clinical studies. The Contractor will not be required to follow the traditional method of commercial vaccine preparation for production of a Master and Working Virus Banks. Alternatively, the LID will provide the contractor sufficient seed virus to inoculate the substrate used for Clinical Lot production (e.g., Vero cells or SPF eggs). The contractor shall confirm microbial sterility of material provided by LID before initiating Clinical Lot production. Next, the experimental lot of vaccine is produced and the bulk harvest is frozen at minus 70 degrees C (in some cases final filling can be done on the day of harvest for small lots of vaccine). For the bulk harvest, the titer of virus (performed by contractor or LID/NIAID), its nucleotide sequence (performed by LID/NIAID), markers of attenuation (performed by LID/NIAID), and its microbial sterility (i.e. absence from contamination with bacteria, fungi, and mycoplasma - performed by contractor) are determined. It is estimated that this might take three weeks to complete. It is estimated that up to 30% of such attempts might fail to meet all three of the above criteria. Those lots that meet titer, sequence, and sterility requirements are filled and further tested for absence from the full set of likely adventitious agents. LID will supply sufficient quantities of antiserum against the virus in the experimental lot of vaccine to be used in the in vitro tests performed to detect the presence of adventitious viral agents in the vaccines. LID will supply qualified Vero cells for production of vaccines. Any offeror must be able to document the experience and capabilities of the 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. It is proposed that any contract issued will be a Fixed-Fee, Indefinite-Delivery Indefinite-Quantity, Requirements contract for a base year and six option years. The RFP will be issued on or about December 16, 2002. All requests for the RFP must be in writing (electronic request will not be accepted) and directed to: Ivan Hernandez, Contracts Specialist, Acquisition Management and Operations Branch National Institutes of Allergy and Infectious Diseases, National Institutes of Health 10401 Fernwood Road, Room 2NE-06, MSC 4813, Bethesda, MD, 20817-4813 This announcement does not commit the Government to award a contract. Collect calls will not be accepted.
- Place of Performance
- Address: Contractor's Location
- Record
- SN00212927-W 20021201/021129213146 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |