This Pre-Solicitation opportunity was posted on March 7, 2013. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Biosafety Testing of GMP Master Cell Banks (MCB) and Retroviral Vectors for NCI Clinical Trials

Awarded

N02RC36004-85Federal

Submission Closed03/22/2013, 04:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 541380

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POSTED

about 18 hours ago

DEADLINE

in 14 days

AI Contract Overview

The National Cancer Institute's Center for Cancer Research, Surgery Branch, is seeking a single contractor to provide biosafety testing for GMP Master Cell Banks and retroviral vectors to support clinical trials. This requirement is structured as a firm fixed price, indefinite delivery indefinite quantity contract with an initial twelve month period of performance and four one year options. The procurement follows commercial acquisition procedures under FAR Part 12 and FAR Part 13.501, with a NAICS code of 541380 and a business size standard of 14 million dollars. The scope of work is divided into two primary packages. Package 1 involves the certification testing of one to ten master cell banks per year, encompassing a wide array of assays including sterility, mycoplasma, viral contaminants, and various PCR tests for human and animal viruses. Package 2 requires certification testing for one to ten retroviral vector supernatants per year, focusing on sterility, mycoplasma, endotoxins, and replication competent retrovirus analysis. All testing must be conducted in accordance with current FDA guidelines, and contractors must be registered in the System for Award Management to be eligible for the award.

General Info

Agency

N/A

Contract Value

$89,113.67

NAICS

541380 - Testing Laboratories and Services

Place of Performance

MD, USA

Set-Aside

NONE

Awardee

BIORELIANCE CORPORATION

Award Issued Date

11/22/2013, 12:00:00 AM UTC

Documents

No documents available

Documents will appear here when they are available.

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Timeline

PhaseAwarded

PostedMar 7

Presolicitation

AwardedNov 22

Contract was awarded

Submission Closed

03/22/2013, 04:00:00 PM UTC

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Organization & Contact Information

AgencyN/A

Contacts2 people available

OfficeN/A

Organization / Agency

N/A

Office AddressN/A

Contacts

Terry GallowayContract

contact@example.gov

+1 (555) 000-0000

Anita HughesContracting Officer

contact@example.gov

+1 (555) 000-0000

Full Description

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 8909 Medical Center Drive, Room 1E136, Bethesda, MD 20892-9705. Description The National Cancer Institute (NCI), Center for Cancer Research (CCR), Surgery Branch (SB) 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 $14M. 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. It has been determined there are no opportunities to acquire green products or services for this procurement. Investigators in the Surgery Branch are involved in the conduct of laboratory and clinical research aimed at improving the care, management, and outcome of patients with cancer. An emphasis is placed on the translation of laboratory findings into the development of clinical protocols. Clinical efforts emphasize the development of new approaches to the immunotherapy of cancer, to the diagnostic and prognostic evaluation of solid tumors, as well as the development of innovative surgical and adjunctive approaches to the treatment of patients with primary and metastatic cancer. 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 the solicitation from Terry Galloway, Contract Specialist via electronic mail at contact@example.gov or fax +1 (555) 000-0000. Interested parties shall include the name of company; complete mailing address; point of contacts, phone, fax numbers, and email address; company DUNS number and business size. All questions shall be in writing and may be addressed to the aforementioned individual noted above. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM.gov). Reference: N02RC36004-85 on all correspondence.