MODIFICATION
A -- Preparation of a stably transfected cell line that expresses monocolonal antibody to VP7 of human rotavirus
- Notice Date
- 7/5/2016
- Notice Type
- Modification/Amendment
- NAICS
- 325199
— All Other Basic Organic Chemical Manufacturing
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2016-98485
- Archive Date
- 7/22/2016
- Point of Contact
- David S Dombeck, Phone: 7704882695
- E-Mail Address
-
ddombeck@cdc.gov
(ddombeck@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- EDIT:The Centers for Disease Control and Prevention, NCIRD/DVD, 1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a sole source contract in accordance with FAR 6.302-1 to Caprico Biotechnologies, Inc., 400 Pinnacle Way, STE 430, Norcross, GA 30071 to acquire stably transfected cell lines that express monoclonoal antibodies of VP7 human rotavirus. The statutory authority permitting other than full and open competition is 41 U.S.C. 253(c)(1) as cited in FAR 6.302-1, "Only one source is capable of providing the supplies or services required. The National Center for Immunization and Respiratory Disease has a requirement to develop a stably transfected cell line that expresses a monoclonal antibody to human rotavirus viral protein (VP7). After posting a sources sought notice on June 7, 2016 and receiving no responses by June 27th, 2016, CDC has determined that no other sources exists which can satisfy the requirements of this statement of work. Accordingly, CDC will issue a sole source procurement unless a capable vendor submits their capabilities. Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contracting Officer within 5 days from the posting date of this notice, their written capabilities statement, proposal or quotation which shall be considered by the agency. Please forward the capability statement and/or pricing information to David Dombeck, Contract Officer, Reference 2015-80812, Centers for Disease Control, Procurement and Grants Office, ATTN: David Dombeck, MS: K-14, 2920 Brandywine Road, Atlanta, GA 30341. All vendors must be registered in the System for Award Management (SAM) prior to an award of a federal contract. The website is: www.sam.gov. The Government will review any/all capabilities statements and pricing information submitted and determine if other qualified sources do exist that could provide this requirement. Information received in response to this announcement will be used solely for the purpose of determining whether to conduct a competitive procurement. If no affirmative responses are received within 3 days, negotiations will be conducted with Caprico Biotechnologies, Inc., as the only source and a contract will be issued without any additional notices being posted. ORIGINAL: TITLE: Preparation of a stably transfected cell line that expresses monoclonal antibody to VP7 of human rotavirus OPDIV: CDC, OID/NCIRD/DVD This is a SOURCES SOUGHT NOTICE to determine the availability of potential businesses capable of meeting the requirements defined below. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. This is not an invitation for bid, request for proposal, or other solicitation, and in no way obligates the Centers for Disease Control and Prevention (CDC) to award a contract. I.BACKGROUND Currently licensed oral rotavirus vaccines RotaTeq and Rotarix are effective in preventing severe diarrhea among children in developed and middle- income countries, but are significantly less effective in the developing world. In addition, both vaccines are associated with a low risk of diarrhea and intussusception among infants who receive the first dose of vaccine. To improve the safety and efficacy of oral rotavirus vaccines, the Centers for Disease Control and Prevention (CDC) has developed a proprietary inactivated rotavirus vaccine (IRV) technology (new human strain and a novel method for rotavirus inactivation) and demonstrated the immunogenicity in mice and protective efficacy in piglets of this IRV by intramuscular (IM) administration. With the establishment of proof of concept for IRV in pre-clinical studies, CDC awarded a Small Business Innovation Research (SBIR) phase I contract to Meridian Life Science in Memphis to conduct a feasibility study for the manufacturing scalability of our IRV In 2013. The success in the project led to the award of first ever SBIR phase II contract from CDC in 2014, which has allowed Meridian to develop and validate a scalable manufacturing process, including inactivation and development of standard operation procedures, for this vaccine. Built upon the progress in our R&D and manufacturing activities, in 2015 the Bill and Melinda Gates Foundation awarded CDC a grant to further support manufacturing of a pilot vaccine lot for pre-clinical toxicology testing and advance phase I clinical trials of the IRV in healthy adults in the United States. Availability of key reagents and assays is critical to support the manufacturing and release of this IRV. To support this effort, CDC has developed an enzyme immunoassay using a rotavirus-specific monoclonal antibody in our research lab. This monoclonal antibody is produced from transiently expressed mammalian cells using two plasmid constructs. This process is labor intensive, costly and difficult to validate. CDC now propose to produce this monoclonal antibody from a stably transfected mammalian cell line, which will give CDC unlimited supply of this critical reagent. CDC plans to contract this service to Caprico Biotechnologies, Inc. which has experience and expertise in the field. Specific Aims: 1)Develop a stably transfected cell line that expresses a monoclonal antibody to human rotavirus viral protein (VP7). 2)Produce and purify monoclonal antibody in high yield. 3)Perform biotinylation of monoclonal antibody and use this biotinylated antibody to develop an enzyme immunoassay. 4)Help validate the assay for use in potency evaluation of IRV. II.PURPOSE To develop a stably transfected mammalian cell line that expresses a monoclonal antibody specific to rotavirus VP7 protein, produce and purify this monoclonal antibody in high yield, and develop an enzyme immunoassay to support potency testing of an IRV. III.SCOPE OF WORK The vendor will need to provide the facility and all labor, materials, and assays required to complete the tasks outlined below. The vendor has to demonstrate track record and prove to have experience and expertise in the field. IV.TASKS TO BE PERFORMED 1.Prepare proposal and protocol. 2.Prepare plasmid DNA for use in transfection. 3.Develop stably transfected mammalian cell line or cell lines. 4.Assess the stability of transfected cell lines and evaluate the production of monoclonal antibody, including antibody isotype and yield. 5.Produce and purify monoclonal antibody, and prepare antibody conjugate by performing biotinylation. 6.Develop and qualify an enzyme immunoassay using biotin-conjugated monoclonal antibody. 7.Provide transfected cell lines, biotin-conjugated monoclonal antibody and final report. 8.Destroy the two plasmid constructs and provide a confirmation letter at the completion of this project. 9.Help prepare manuscripts for publication. The scale of production needed to achieve expected yield is 10 Liter. V.GOVERNMENT FURNISHED MATERIALS CDC will provide the vendor with plasmid DNA expressing monoclonal antibody to rotavirus, and necessary laboratory support, including reagents and assays for the experiments. VI.PERIOD OF PERFORMANCE The period of performance shall commence upon receipt of the purchase order and shall continue for the period of time as indicated in the protocol. October 15, 2016 to April 30, 2017 VII.DELIVERABLES The vendor shall provide the following deliverables to the Project Officer by the dates reflected below. All electronic files should be delivered in MS Word format and provided via e-mail. DeliverablesDate Required Preparation of research proposal and protocolsJuly 15, 2016 Development of stably transfected mammalian cell lineSeptember 15, 2016 Production, purification, characterization and conjugation of monoclonal antibodyDecember 31, 2016 Support development and qualification of enzyme immunoassayJanuary 31, 2017 Summary reportMarch 31, 2017 VIII.MINIMUM VENDOR QUALIFICATIONS The vendor shall have an established R&D facility and have experience in cell line development, monoclonal antibody work and relevant areas, such as assay development and qualification. The vendor shall have expertise and understand issues in the development of monoclonal antibody reagents and assays to support the research and development of human vaccines. The provider must have a R&D facility and an excellent track record in the area of cell line engineering research and assay development. The provider's investigators should have sensitivity to the issues of reagent and assay development in compliance with regulatory requirements. The investigators should also have all reagents and assays in place to complete all required laboratory tests. The contractor's laboratory will support the development and qualification of enzyme immunoassays to be done at CDC. Qualification work should be completed 60 days after the completion of assay development. The provider will send any remaining reagents to the Viral Gastroenteritis laboratory at CDC, 90 days after completion of the project. The provider will work together with scientists at CDC to analyze the data and prepare a final report, 120 days after completion of the experiment. The provider and CDC scientists will jointly prepare manuscripts for publication, 180 days after completion of the project. Capability statements must demonstrate the minimum requirements outlined above. Please address each in the order listed above. Please provide the follow Business information: 1.DUNS Number 2.Company Name 3.Company Address. 4.Company Point of Contact, phone number and email address 5.Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. 6.Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7.Current GSA Schedules appropriate to this Sources Sought 8.Current Government Wide Agency Contracts (GWACs) 9.Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. 10.Responders should also include a statement about whether or not they have an approved Federal audited accounting system. If the responder has an approved accounting system, please provide the certification in which the accounting system was deemed adequate (e.g. the name of the audit agency and audit number). You may submit as an attachment, which will not count towards the overall page limit. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email or regular mail to the point of contact listed below. Responses shall be limited to 5 pages. Responses must be received not later than Wednesday, June 9th, 2016 at 12:00 p.m. (Eastern Standard Time). Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: David Dombeck at vwj8@cdc.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2016-98485/listing.html)
- Place of Performance
- Address: 1600 Clifton Road, Atlanta, Georgia, 30329, United States
- Zip Code: 30329
- Zip Code: 30329
- Record
- SN04171761-W 20160707/160705235015-b8bde27dcc76e142b66c8584f2b82d75 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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