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Establishment of Chemically Defined Culture - SOW

General Information

Document Type:PRESOL
Posted Date:Aug 29, 2017
Category: Special Studies and Analyses - Not R&D
Set Aside:N/A

Contracting Office Address

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

Description

SOW The Centers for Disease Control and Prevention intends to award a sole source firm fixed price purchase order to Caprico Biotechnologies, Inc., 400 Pinnacle Way, Ste 430, Norcross, Ga 30071 to generate an engineered cell line HB-K10-BH, which stably expresses and secretes recombinant humanized monoclonal antibody against VP7 protein of a human rotavirus serotype G1. The company successfully made this engineered cell line, produced and purified recombinant monoclonal antibody in small scale stationary culture, and established enzyme-linked Immunosorbent Assay (ELISA) for detecting IRV based on biotin-conjugate recombinant antibody, thus established the proof of concept for using this monoclonal antibody for the development of assays to support clinical trials of CDCs proprietary inactivated rotavirus vaccine (IRV). With this success, we now would like to propose a follow-up contract to develop a scalable manufacturing process to produce pure recombinant antibody using bioreactor (30-50 liters) in serum-free media, further optimize the process of the antibody production and conjugation, and qualify an enzyme immunoassay to support IRV development. Because this is a follow‐up contract service to continue optimizing a scalable process and qualify an assay to support the clinical development of IRV, no other vendors or products that will meet our need.This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) (SAP) and 10 U.S.C. 2304(c)(1). Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive quotations; however, all quotations/responses received within five (5) days of the issuance of this notice will be considered by the government. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to Maria Shamburger, Contracting Officer at heg9@cdc.gov by COB 9/4/2017.

Original Point of Contact

POC Maria S Shamburger,

Place of Performance

Address:
1600 Clifton Road, Atlanta, Georgia, 30329, United States
30329,
Link: FBO.gov Permalink
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