SOW swine macrophages (002).dg.docx

Statement of Work – Macrophage Immortalization

1.0 INTRODUCTION:

The USDA, ARS, Plum Island Animal Disease Center (PIADC) in Orient Point, NY, requires primary cells of swine macrophages to be developed into an immortalized cell line. Currently African swine fever virus can only replicate in primary swine macrophages, which are difficult to produce, as they have to be freshly isolated from either swine blood or swine lungs. For large scale production of ASFV vaccine candidates, primary cells cannot be used. Several commercially available commercial cell lines of swine macrophage origin have been tested and do not replicate ASFV at levels needed for vaccine production. Therefore, the Agency seek to have primary swine macrophage cells isolated from blood or lung immortalized though various methods, including but not limited to induction of immortalization though hTert using viral or non-viral methods.

Immortalized swine macrophages will allow us to A. Grow and test African Swine Fever Virus vaccine candidates.

B Produce large batch of vaccine candidate for animal testing and seed vaccine preparation.

C. Conduct study of the biology of African swine fever virus.

D. Isolate new and emerging field strains E. Perform tests for antivirals and other control methods

2.0 CONTRACTOR REQUIREMENTS:

Vendor requirements: The vendor shall provide immortalized swine macrophages from both Lung and Blood.

REQUIREMENTS –

For both Lung and Blood Derived macrophages the contractor shall provide:

· Immortalized pool of swine macrophages will be delivered on dry ice

· 20 individual clones and estimated growth rate of immortalized swine macrophages ( 20 from blood derived and 20 from lung derived macrophages)

· 3 vials (106 cells/vial) for each clone will be delivered on dry ice

· Growth conditions will be provided including instructions for media requirements, freezing, splitting of cells

· Ideally a non-fluorescent marker will be used for selection of immortalized swine Macrophages

Optimally immortalization will be done using methods already acceptable or favorable for vaccine production, with vendor provided documentation of favorability of these methods.

3.0 ADDITIONAL REQUIREMENTS:

• WARRANTY – The vendor will guarantee passage of cells for at least 20 times after receiving them.

• DOCUMENTATION – The Contractor shall provide the following:

a) Growth conditions will be provided including instructions for media requirements, freezing, splitting of cells

b) Antibiotic selection and methodology of transduced cells including the sequence of any insertion cassette, and a description of where the insertion cassette was inserted.

c) Confirmation of transgene expression by RT-PCR or equivalent method

d) Mythology of amplification of selected clones and cryopreservation

e) Viability test after cryopreservation

f) The Contractor shall guarantee that the immortalized cells are able to be passed 20 times after the government receives them.

• • Delivery Time is determined by the Vendor’s availability of the product

• Performance - The Contractor shall furnish and deliver immortalized macrophages within one year of the award.

8.0 GOVERNMENT RESPONSIBILITY: The government will provide the required amount of primary swine macrophages derived from lung and blood. And growth media to perform immortalization. With a maximum of 1X10^8 cells and 1L of growth media

13.0 EVALUATION CRITERIA: The government intends to make an award to 3-6 entities which can be offering to immortalize blood derived swine macrophages and/or lung derived macrophages. The award to entities offering the "best value" to the Government, price and the identified "technical factors" considered. All of the technical factors combined are significantly more important than price; however, in the event that offers are considered essentially equal in terms of technical competence, price may become the determining factor (inclusive of all line items) in contract selection. The government intends to make an award based on the lowest evaluated price (inclusive of all line items) and other factors considered.

14.0 SUBMISSION OF INVOICES

a) The Contractor shall submit an original monthly invoice to IPP at the website listed below:

"Submit Invoice-to" address for USDA orders is the US Department of Treasury's Invoice Processing Platform (IPP). All invoices are to be submitted online via the electronic Invoice Processing Platform. This is a mandatory requirement initiated by the US Department of Treasury and you can find more information at this website https://www.ipp.gov/index.htm. Your company must register at https://www.ipp.gov/vendors/enrollment-vendors.htm to establish an account to submit an invoice”.

c) Invoices will be processed for payment in accordance with the U.S. Prompt Payment Act.

-End of Statement of Work -