RheoSense M-VROC-II Viscometer System (AMBIS 2229066)

This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Rheosense, Inc,, 12667 Alcosta Blvd, # 100, San Ramon, CA 94583-5272, United States, to procure a m-VROC II system.

The purpose of this procurement is to secure a Rheosense, Inc. m-VROC II viscometer system.

The National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 50 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world.

Within NIAID, the Vaccine Production Program (VPP) is the development arm of the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). The mission of the VRC is to create and develop potentially lifesaving vaccines for HIV, Ebola, Zika, Malaria, SARS-COV-2 and other known pathogens and get these potentially lifesaving products into the clinic. The viscosity of these vaccine candidates is a critical quality attribute that significantly impacts both cGMP manufacturing and administration to patients in the clinic.

Project Background:

Viscosity is a key solution characteristic that can influence the everyday handling, manufacturing, and administration of vaccine products. Particularly for higher concentration (>50 mg/mL) products, viscosity is a key product characteristic that is optimized and monitored throughout development. This equipment is being purchased to support the production of vaccine products at the VPPL. The m-VROC (version 1) viscometer is currently in use at the VPPL for viscosity measurements of vaccines and solutions. The m- VROC II is the current model equivalent, and is being purchased as a replacement for the aging m-VROC (purchased in 2011). The m-VROC II is requested as it is the only instrument that meets the program requirements:

1. Continuity of operations in regards to equipment, analysis methods, and standard operation

procedures at the VPPL

2. Continuity with current instrumentation (the RheoSense Initium, used for high throughput

viscosity measurements at the VPPL)

3. Low required sample volume

4. Temperature control

5. Broad measurement range

Description of the supplies or services to be purchased:

mVROC-II system and associated measurement chips including:

1. mVROC-II system, software included
2. mVROC-II starter kit
3. 100 uL syringe
4. 2.5 mL syringe
5. Aluminum reservoir
6. B05 measurement chip

7. A05 measurement chip

Only one award will be made as a result of this solicitation. This will be awarded as a firm-fixed price type of contract.

Delivery: Estimate delivery is 90 days after receipt and acceptance of award.

Delivery Location: NIH/NIAID/VPP, 9 West Watkins Mill Road, Gaithersburg, MD 20878.

The statutory authority for this sole source requirement is 41 U.S.C. 253 (c) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement via the NIAID eSASS system at https://esass.nih.gov/ by 4:00 pm EASTERN Standard Time, Friday, July 25, 2024. All vendors must register in the eSASS system in order to submit a capability statement. Instructions on how to register are included on the website. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.