ANC UoC J and A_..pdf

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Command (NMRC), at 503 Robert Grant Avenue, Silver Spring, MD 20910 on behalf of the NMRC’s, Diagnostics and Surveillance Department (DSD) to meet Naval Medical Research requirements.

2. Nature and/or description of the action.

The proposed action is to acquire services to produce antibody-nanoparticle conjugates and ship to NMRC/DSD. It is for a one year firm fixed price award to University of Chicago address: 5801 S Ellis Avenue, Chicago, IL60637.

3. Description of Supplies or Services:

NMRC’s Diagnostics and Surveillance Department (DSD) has a need to obtain engineered nanoparticles coated with anti-dengue monoclonal antibodies for targeted delivery to kill dengue virus. This type of nanoparticles is not available in the market for direct purchase. To this end, the photothermal nanoparticles and the antibody-coating strategy by Dr. Huang’s lab in University of Chicago is being requested. The estimated value for the acquisition is $50,000. Dr. Huang’s lab shall: a) Design and prepare biocompatible photothermal nanoparticles with anti-viral nature for appropriate composition, size, and uniform distribution. b) Conjugate anti-Dengue monoclonal antibodies onto nanoparticle surface. make two antibody-nanoparticle products. c) Determine the conjugation efficacies and densities of antibodies on nanoparticles and provide the quality and quantity data for NMRC for approval. d) Optimize surface densities of antibodies on nanoparticles for treatment. e) ship antibody-nanoparticle conjugates to NMRC.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1) and FAR 13.106-1(b)(1) soliciting from a sole source.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

There are a variety of Nanoparticles in the market; each has its own chemical or biological composition. Lipid nanoparticles can encapsulate drugs which is a common strategy to deliver drug to infected cells. However, encapsulating drugs inside the nanoparticles is an additional and technically challenging step compared to nanoparticles possessing anti-viral property. Metal nanoparticles are another class of nanoparticles with anti-viral nature; however, most reports on metal nanoparticles were at in vitro stage as very few of them proceeded to in vivo animal stage. The work performed by Dr. Huang’s study at the University of Chicago had both in vitro and in vivo data showing how the photothermal nanoparticles his lab made can inhibit SARS-CoV-2 both in vitro in cells and in vivo in mice. In addition, Dr. Huang’s lab coated the nanoparticles with anti-SARS-CoV-2 antibodies which helped for targeted delivery of the nanoparticles to infected cell. These photothermal nanoparticles can absorb lights and emit energies to kill the virus.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. A synopsis of the proposed procurement will be published to the government point of entry in accordance with FAR 5.202.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

In May 2024, research was conducted by searching the internet, emailing, and calling potential vendors to find out their capabilities and pricing. The following companies were found:

Promab.com: The company makes lipid nanoparticles for mRNA delivery which does not fit what we need.

FortisLife.com: Emailed, no response.

Wuxi XDC: Emailed, no response.

Rapid Novor: Services included antibody sequencing, antibody discovery, antibody epitope mapping, antibody expression, and antibody characterization. No antibody conjugation. No nanoparticle-drug encapsulation.

Ascendia Pharmaceuticals: The company only provides nanoparticles and production of nanoparticles. No antibody and no conjugation.

Encapsula NanoSciences: The company only provides nanoparticles and production of nanoparticles. No antibody and no conjugation.

Creative Biolabs: Provides liposome nanoparticle which is not antiviral by nature.

Cellmosaic.com: Emailed and responded with no service.

Bocsci: Emailed and responded with no service.

9. Other facts supporting the use of other than full and open competition.

N/A

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

Notices required by FAR 5.201 shall be published.

Jun Huang, Ph.D., Principal investigator Associate Professor of the Pritzker School of Molecular Engineering of the University of Chicago has expressed interest in this acquisition.

To date, no other sources have written to express an interest. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

This is a one-time buy, for the reasons set forth in Paragraph 5, NMRC has no plans at this time to compete future contracts for the types of supplies/services covered by this document. If another potential source emerges, NMRC will assess whether competition for future requirements are feasible.

12. Point of Contact:

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification is Vania Harrison, Contracting Officer in the Material Management Department (MMD) and can be reached by emailing priscilla.v.harrison.civ@health.mil.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance Digitally signed by

SUN.PEIFANG.1269418318

301-319-7446 09/03/2024 269418318 Date: 2024.09.03 14:52:28

-04'00'

Name: Peifang Sun Phone Date Title: PI Department/Command: DSD/DIDD

Requirements Cognizance

HALL.ERIC.REESE.1

037970383

Digitally signed by

HALL.ERIC.REESE.1037970383

Date: 2024.09.04 09:55:07 -04'00'

301-319-7475 09/03/2024

Name: Eric Hall Phone Date Title: Department Head Department/Command: DSD/DIDD

SUN.PEIFANG.1

mailto:priscilla.v.harrison.civ@health.mil

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

Contracting Officer Phone Date

HARRISON.PRISCI Digitally signed by

HARRISON.PRISCILLA.V.155325893

LLA.V.1553258932 2

Date: 2024.09.04 15:56:37 -04'00'