Protein Production for CVV

The Centers for Disease Control and Prevention (CDC), the Vaccine Preparedness Team of the Virology, from the Virology Surveillance and Diagnosis Branch within the Influenza Division of the CDC intends to competitively procure through full and open competition of recombinant antibodies. The overall objective is to provide the Influenza Division with recombinant proteins and antibodies, then help further characterize selected proteins and antibodies in the formation of binding complexes and binding kinetics (the interactions between two molecules, for example, a receptor and viral attachment glycoprotein). The Vaccine Preparedness Team of the Virology, from the Virology Surveillance and Diagnosis Branch within the Influenza Division of the CDC, shall be the principal scientific and technical party representing the Government’s needs, working with an indetermined Contractor from selected Offerors. Proteins and/or antibodies created from the proposed work, whether or not they have also been sent to CDC, and/or proteins, antibodies, or sera from the CDC may be sent to the Contractor for further characterization tests, not to exceed those listed in §3 and §4. Requirements: Task 1: Fifty (50) small-scale preparations of recombinant viral proteins expressed in a mammalian production line: Produced in HEK293 or similar cells. The CDC will provide a digital sequence. Contractor to perform gene synthesis and vector construction. Then, expression from said vector in sufficient volume to ensure minimum yield following purification. Minimum yield is 1mg per preparation. Target purity is SDS-PAGE>90% Task 2: Five (5) mid-scale preparations of recombinant viral proteins expressed in a mammalian production line: Produced in HEK293 or similar cells. The CDC will provide a digital sequence. Contractor to perform gene synthesis and vector construction. Then, expression from said vector in sufficient volume to ensure minimum yield following purification. Minimum yield is 10mg per preparation. Target purity is SEC-HPLC>90% Task 3: One hundred (100) screen-scale preparations of recombinant antibodies expressed in a mammalian production line: Produced in HEK293 or similar cells. The CDC will provide a digital sequence. Contractor to perform gene synthesis and vector construction. Then, expression from said vector in sufficient volume to ensure minimum yield following purification. Minimum yield is 50ug per preparation. One-step purification. Task 4: Twenty (20) small-scale preparations of recombinant antibodies expressed in a mammalian production line: Produced in HEK293 or similar cells. The CDC will provide a digital sequence. Contractor to perform gene synthesis and vector construction. Then, expression from said vector in sufficient volume to ensure minimum yield following purification. Minimum yield is 1mg per preparation. One-step purification. Task 5: Five (5) mid-scale preparations of recombinant antibodies expressed in a mammalian production line: Produced in HEK293 or similar cells. The CDC will provide a digital sequence. Contractor to perform gene synthesis and vector construction. Then, expression from said vector in sufficient volume to ensure minimum yield following purification. Minimum yield is 10mg per preparation. Two-step purification. Task 6: 120 BLI screenings of HA-binding to sialic acid receptors or BLI screening of antibodies against target proteins. Samples likely to be derived from Tasks 1-5, but depending on the results may be substituted by other proteins or antibodies available to CDC. Expected to run on Octet or similar instrument. Capture of HA in BLI to be done using sialic acid receptor analogs: α2,6-sialyl-N-acetyllactosamine α2,3-sialyl-N-acetyllactosamine Task 7: ELISA screening of 100 antibodies: Samples are likely to be derived from Task 3, but other antibodies available to CDC may be substituted depending on the results. May require up to 3-point ELISA testing Task 8: SPR screening of five (5) antibodies: Samples are likely to be derived from Task 5, but other antibodies available to CDC may be substituted. The Government will release the solicitation, including any subsequent amendments on the SAM.gov website. The Government anticipates the solicitation will be available approximately 5 days from the date of release of this notice, with an anticipated closing date/proposal due date of 10 days from the date of release of solicitation. No telephone or written requests for the solicitation will be accepted. After solicitation release, vendors should regularly access the website to access any updates. Attachments: 1. SOW