SOLICITATION NOTICE
B -- Biosafety Testing of GMP Master Cell Banks (MCB) and Retroviral Vectors
- Notice Date
- 12/19/2008
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- RFQ-NCI-90025-NG
- Archive Date
- 2/5/2009
- Point of Contact
- Malinda L Holdcraft,, Phone: (301) 402-4509, Caren N Rasmussen,, Phone: (301) 402-4509
- E-Mail Address
-
holdcram@exchange.nih.gov, cr214i@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI) plans to procure Biosafety Testing of GMP Master Cell Banks (MCB) and Retroviral Vectors for NCI Clinical Trials. This acquisition will be conducted under the procedures for acquiring commercial buys as authorized in FAR Part 12 and under the authority to use simplified procedures for commercial requirements as authorized in FAR PART 13.501. The North American Industry Classification System Code is 541380 and the business size standard is $12M. The NCI will require the biosafety testing of between 1 and 10 cGMP quality master cell banks and retroviral vector supernatants, per year. The NCI will supply to the contractor, vials of cells from a given master cell bank and/or retroviral vector supernatants for testing. The contractor shall be responsible for development of Standard Operating Procedures (SOP’s), Quality Assurance (QA) practices, qualifications of production components, preparation of batch records, and the issuance of a final report containing the certificates of analysis, for the stated assays which will comply with current Points to Consider and 21CFR regulatory guidelines as stipulated by the Food and Drug Administration (FDA). Only one (1) award shall be made as a result of this solicitation. This requirement will be awarded as a firm fixed price, indefinite delivery indefinite quantity (IDIQ) type contract. Period of Performance shall be from award through twelve (12) months; with four (4) one year options. The following Assays are requested for this requirement, which includes the minimum and maximum number for each. Package 1: Requirements for Biosafety Testing of Master Cell Banks (MCB). The NCI will provide between 1 and 10 cGMP quality master cell banks per year to the contractor for biosafety testing. The contractor will be responsible for conducting master cell bank certification testing based on current FDA guidelines. Subject to review and/or change of current FDA requirements, MCB certification tests will include the following list of assays. In some instances, more than one type of assay is available for product testing. In those cases, a different assay may be used than those listed below as long as the assay is validated and documentation can be provided demonstrating the assay in question satisfies current FDA regulatory guidelines. Any additional changes shall be made by separate modification to this order. A.Test for the presence of bacterial and fungal contaminants: four media sterility test using a direct inoculation method. QUANTITY: Minimum of 1 - Maximum of 20 B.Test for the presence of agar-cultivable and non-cultivable mycoplasma according to 1993 PTC and 21CFR 610.30. QUANTITY: Minimum of 1- Maximum of 20 C.Cell culture identification and characterization. QUANTITY: Minimum of 1 - Maximum of 10 D.Cocultivation of producer cells with human 293 cells and detection of replication competent retrovirus by feline S+L- assay (GALV RCR analysis). QUANTITY: Minimum of 1 - Maximum of 10 E.Direct inoculation of EOP culture supernatant for detection of replication competent retrovirus by amplification in human 293 cells and detection by feline S+L- assay (GALV RCR analysis). QUANTITY: Minimum of 1 - Maximum of 10 F.Cocultivation of test article cells with SC-1 cells and detection of retrovirus by reverse transcriptase and XC plaque assay (Ecotropic RCR analysis including MLV) QUANTITY: Minimum of 1 - Maximum of 10 G.In vitro assay for the presence of viral contaminants. QUANTITY: Minimum of 1 - Maximum of 10 H.Test for the presence of inapparent viruses. QUANTITY: Minimum of 1 - Maximum of 10 I.Mouse antibody production (MAP) test. QUANTITY: Minimum of 1 - Maximum of 10 J.In vitro assay for the presence of bovine viruses according to 9CFR requirements. QUANTITY: Minimum of 1 - Maximum of 10 K.In vitro assay for the presence of porcine viruses according to 9CFR requirements (modified 9CFR requirements when tested in conjunction with bovine 9CFR screen). QUANTITY: Minimum of 1 - Maximum of 10 L.Polymerase chain reaction assay for the detection of Simian Virus 40 (SV40) in biological samples. QUANTITY: Minimum of 1 - Maximum of 10 M.Polymerase chain reaction assay for the detection of Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in biological samples. QUANTITY: Minimum of 1 - Maximum of 10 N.Polymerase chain reaction assay for the detection of Hepatitis B Virus (HBV) in biological samples. QUANTITY: Minimum of 1 - Maximum of 10 O.Polymerase chain reaction assay for the detection of Human Herpesvirus 6 (HHV-6) in biological samples. QUANTITY: Minimum of 1 - Maximum of 10 P.Polymerase chain reaction assay for the detection of Human Herpesvirus 7 (HHV-7) in biological samples. QUANTITY: Minimum of 1 - Maximum of 10 Q.Polymerase chain reaction assay for the detection of Human Herpesvirus 8 (HHV-8) in biological samples. QUANTITY: Minimum of 1 - Maximum of 10 R.Polymerase chain reaction assay for the detection of Cytomegalovirus (CMV) in biological samples. QUANTITY: Minimum of 1 - Maximum of 10 S.Polymerase chain reaction assay for the detection of Epstein Barr Virus (EBV) in biological samples. QUANTITY: Minimum of 1 - Maximum of 10 T.Polymerase chain reaction assay for the detection of Human T-Cell Lymphtrophic Virus Types I and II (HTLV-I/II) in biological samples. QUANTITY: Minimum of 1 - Maximum of 10 U.Polymerase chain reaction assay for the detection of Human Parvo Virus B19 in biological samples. QUANTITY: Minimum of 1 - Maximum of 10 V.RT-PCR assay for the detection of Hepatitis C Virus (HCV) in biological samples. QUANTITY: Minimum of 1 - Maximum of 10 W.Q-PCR analysis for detection of E1A sequence from Adenovirus in biological samples. QUANTITY: Minimum of 1 - Maximum of 10 X.Transmission EM for viruses and retroviruses. QUANTITY: Minimum of 1 -Maximum of 10 Y.Vector Identity by Southern blot analysis. QUANTITY: Minimum of 1 - Maximum of 10 Package 2: Requirements for Biosafety Testing of Retroviral Vectors. The Surgery Branch will provide between 1 and 10 cGMP quality retroviral vector supernatants per year to the contractor for biosafety testing. The contractor shall be responsible for conducting retroviral vector supernatant certification testing based on current FDA guidelines. Subject to review and/or change of current FDA requirements, Vector certification tests will include the following list of assays. In some instances, more than one type of assay is available for product testing. In those cases, a different assay may be used than those listed below as long as the assay is validated and documentation can be provided demonstrating the assay in question satisfies current FDA regulatory guidelines. Any additional changes shall be made by separate modification to this order. Z.Test for the presence of bacterial and fungal contaminants: four media sterility test using a direct inoculation method. (Up to 6 assays per production run). QUANTITY: Minimum of 6 - Maximum of 120 AA.Test for the presence of agar-cultivable and non-cultivable mycoplasma according to 1993 PTC and 21CFR 610.30. QUANTITY: Minimum of 1 - Maximum of 20 BB.In vitro assay for the presence of viral contaminants. QUANTITY: Minimum of 1- Maximum of 10 CC.Endotoxin, using the limulus amebocyte lysate assay. QUANTITY: Minimum of 1- Maximum of 10 DD.Cocultivation of 1x108 EOP cells with human 293 cells and detection of replication competent retrovirus by feline S+L- assay (GALV RCR analysis). QUANTITY: Minimum of 1 - Maximum of 10 EE.Direct inoculation of 300ml retroviral vector supernatant for detection of replication competent retrovirus by amplification in human 293 cells and detection by feline S+L- assay (GALV RCR analysis). QUANTITY: Minimum of 1 -Maximum of 10 Potential offerors may request a copy of solicitation RFQ-NCI-90025-NG from Malinda Holdcraft, Contract Specialist, via electronic mail at holdcram@exchange.nih.gov or fax at 301-402-4513. It is the responsibility of the Offeror to ensure all requests and/or questions have been received in the contracting office. Please provide your business size; DUNS number; point of contact name, phone and fax numbers, e-mail address, and complete mailing address. If you have questions regarding this notice, they may be addressed to the aforementioned individual. Estimated issue date of the solicitation is January 6, 2009 with an estimated due date of January 21, 2009. No collect calls will be accepted. In order to receive an award, contractors must be registered in and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA). Potential offerors shall reference RFQ-NCI-90025-NG on all correspondence.
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