Establishment of Chemically Defined Culture

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 CDC's 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.