FETAL BOVINE SERUM
THIS IS A SOURCES SOUGHT NOTICE ONLY, 2219-SS53, and a SOLICITATION IS NOT CURRENTLY AVAILABLE The United States Department of Agriculture, APHIS is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support this requirement for:
Fetal Bovine Serum
The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 325413. With a size standard of 1250 emp The Government contemplates a single award for this requirement.
Background
Fetal bovine serum (FBS) is used as a media additive in cell culture for growth promotion. Cell cultures are used for testing associated with infectious viral agents. Testing includes virus isolation, virus neutralization assays, virus production, and reagent production (antiserum, conjugate, and antigen production). These activities are used in diagnosing animal diseases, research, and regulation of veterinary biologics.
FBS from fetal calves is often contaminated with viral material or antibodies that interfere with testing for certain viruses. Specifically, FBS contaminated with Bovine Viral Diarrhea virus (BVDV) or BVDV antibody will interfere with testing for bovine and swine diseases. Infectious BVDV in FBS can infect cell cultures leading to false positive results in virus isolation testing as well as contaminate reagents which could be sent to external consumers. Extraneous BVDV antibodies in the serum will interfere with virus neutralization tests, virus isolation tests, immunoperoxidase VN tests, and reagent production (stock virus, antiserum, conjugate, and antigen). These antibodies may neutralize potentially infectious viruses that can cross react with BVDV antibodies, resulting in false negative results. Other infectious virus, non-infectious viral particles, and antibody may also negatively affect testing.
The Foreign Animal Disease Diagnostic Laboratory (FADDL) is looking to purchase 120 liters of US origin, 100% FBS that meets specified testing requirements. This must be unadulterated, 100% fetal bovine serum that has been gamma irradiated AFTER quality testing described below.
Scope
FADDL expects to purchase of 120 liters of US origin FBS that meets our testing requirements.
Objectives
The FBS must to be free of extraneous infectious viruses and antibodies against certain microorganisms. See provided list. This must be unadulterated, 100% fetal bovine serum that has NOT been gamma irradiated before testing. This FBS will be used in testing required for diagnosing animal diseases and agricultural research.
Tasks
1. The contractor shall provide FADDL with samples from lots of FBS they expect are likely to meet the listed testing specifications. The volume of each sample must be at least 250 ml. FADDL will test these samples for extraneous infectious viruses, and antibodies against certain microorganisms. See provided list. In addition to the extraneous viruses and antibodies, the lots must also be free of bacteria, fungi, and mycoplasma. The hemoglobin level must be lower than 20 mg/dL and the endotoxin level must be lower than 2.5 EU/ml.
2. FADDL will select lots of FBS that are free of the listed antibodies, viruses, and RNA. The number of lots selected will be of sufficient total pooled volume to fall within the total purchase volume. Following acquisition of the FBS, additional testing may be conducted on the delivered product to verify the absence of infectious virus, and antibodies from the list. Any confirmed positive results for the following can cause rejection of the FBS. If rejected, shipment will be returned and re-performance will be necessary at no cost to the government.
Delivery
The contractor shall provide FADDL with FBS samples for testing. The sample from each lot of FBS to be tested must be at least 250 ml in volume.
Once testing requirements have been met and a lot has been accepted, the contractor shall ship the FBS from the selected lot(s) to FADDL where a final round of testing may occur.
Place of Performance
Testing for hemoglobin and endotoxin levels, as well as a certificate of analysis of other comprehensive quality tests must be provided by the contractor. Testing for the listed antigens and antibodies will be confirmed at FADDL on Plum Island, NY.
Period of Performance
Each round of testing by FADDL will take approximately 4-6 weeks to complete. Full contract to be completed within 6 months.
Testing to be performed by FADDL
FBS can be rejected for the presence of any of the following:
Extraneous infectious virus:
• Bovine viral diarrhea and Hobi-like viruses
• Border disease virus
• Bluetongue virus
• Bovine adenovirus
• Bovine parvovirus
• Infectious bovine rhinotracheitis virus (bovine herpesvirus 1)
• Parainfluenza-3 virus
• Bovine respiratory syncytial virus
• Reovirus
• Vesicular stomatitis virus
• Rabies virus
• Senecavirus A
Extraneous antibody:
• Bovine viral diarrhea and Hobi-like viruses
• Border disease virus
• Bluetongue virus
• Infectious bovine rhinotracheitis virus (bovine herpesvirus 1)
• Parainfluenza-3 virus
• Bovine respiratory syncytial virus
• Malignant catarrhal fever viruses
• Vesicular stomatitis virus
• Orf virus
• Pseudorabies virus (suid herpesvirus 1)
There is no solicitation at this time. This request for capability information does not constitute a request for proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred.
If your organization has the potential capacity to perform these contract services, please provide the following information: 1) organization name, address, email address, website address, telephone number, and size and type of ownership for the organization; and 2) tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements.
The government will evaluate market information to ascertain potential market capacity to 1) provide services/supplies consistent in scope and scale with those described in this notice and otherwise anticipated; Based on the responses to this sources sought notice/market research, this requirement may be set-aside for small businesses or procured through full and open competition, and multiple awards may be made. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.
Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this Sources Sought Notice by September 13th, 2019 0900 CST. All responses under this Sources Sought Notice must be emailed to sarah.c.schauf@usda.gov.
If you have any questions concerning this opportunity, please contact: Sarah.C.Schauf@usda.gov.
Sarah C Schauf, Contracting Officer, Phone 5153377572, Email sarah.c.schauf@usda.gov
