JOFOC Redacted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN

COMPETITION

1. Contracting Activity MWA National Center for Agricultural Utilization Research (NCAUR) 1815 N University St.

Peoria, IL 61604

2. Nature/Description of Action The Plains Area (PA) US Department of Agriculture (USDA) Contracting Office intends to award a sole source contract to Satorius Stedim North America, Inc. for three (3) BioStat B Twin MO Bioreactor Dual Control Units with installation.

3. Description of Supplies/Services Bioreactors/fermenters are essential for growing microorganisms under carefully controlled conditions for increased product yields and consistency. They are also essential for preparing for industrial deployment of ARS technology because large-scaled fermentations are grown in bioreactors. They also allow for advanced culturing methods (e.g. fed-batch) and electronic monitoring of environmental conditions and growth characteristics. Typical sensors are included for monitoring pH, dissolved oxygen, excess foaming, and sometimes cell biomass concentration (e.g., turbidity).

Control units allow for control of pH, dissolved oxygen via aeration conditions, stir rate, gas flow into bioreactor, and possibly gas inflow composition. Control units are equipped with an array of pumps for adding acid or base, an antifoam agent, and nutritional ingredients, and removing culture (for continuous flow cultures).

At this time, three (3) additional BioStat B Twin MO Bioreactor Dual Control Units are needed to support the NCAUR mission. The BioStat B Twin MO units are the only know products that meet the following specifications:

Compatible with our current Biostat benchtop bioreactor vessels including stirring mechanisms and water-based temperature control.

Configurable in a similar way to existing larger Biostat stirred tank bioreactors for seamless scale-up from laboratory scale to large scale (100L working volume).

Capable of controlling up to two vessels completely independent of each other. Equipped with screen to display culture conditions.

Gassing rates up to 2 vvm (volume of air per volume of culture per minute) with air, O2, or N2 connections to allow for controlled gas mixtures.

Compatibility with current jacketed water-based temperature control system for vessels

a. Connections for double wall UniVessel Glass

b. Needs to be able to connect to water chiller

4. Statutory Authority In accordance with FAR 13.501, there is only one source available to complete this

5. Demonstration of Contractor’s Unique Qualifications and/or Product’s Unique Features The NCAUR maintains a common fermentation facility equipped with multiple B.

Braun Biostat benchtop bioreactors. Scientists using these bioreactors have amassed large amounts of historical data using this style of control system, but more importantly, using a consistent style of fermentation vessel. The system is also matched to larger Biostat bioreactors housed in the pilot facility next door for convenient scaling to larger volumes. Bioreactor vessels at NCAUR are double-walled, water cooled, and were originally supplied by B. Braun. Sartorius has since purchased B. Braun and is now the only vendor qualified to meets our needs, providing: (a) advanced control options required for conducting precision fermentations and implementing sophisticated culturing schemes; (b) an array of state of the art sensor options for monitoring cell growth and microbiological culture conditions; (c) flexible control systems that allow for control of 2, 5, and 10 L bioreactor vessels, (d) guaranteed backward compatibility with our current bioreactor vessels, (e) are matched to larger Biostat bioreactors (100L) housed in our pilot facility for convenient scaling up for culture volumes, and (f) continuity with historical data set.

6. System for Award Management (SAM.gov) Announcement/Potential Sources A Sources Sought notice was posted to SAM.gov on 08/06/2024, with responses due 08/09/2024. No sources responded to the Sources Sought.

7. Determination of Fair and Reasonable Cost

The cost will be evaluated to determine fair and reasonable prior to award.

A search of the Federal Procurement Data System (FPDS) will assist in this process.

Comparison to the IGE will also be reviewed.

8. Market Survey While it is the intent of the USDA to promote competition wherever possible, no other product can meet the required specifications due to the proprietary nature of the equipment involved.

9. Additional Support The USDA has millions of dollars invested into the current research environment. It would be wasteful, irrational, and cause unnecessary delays to replace the existing equipment when compatible equipment is still available on the market. At this point, it is in the best interest of the Government to purchase the additional three (3) units to ensure compatibility with the existing proprietary environment and continue mission support.

10. Other Interested Sources There are no other interested sources. A Sources Sought notice was posted to SAM.gov on 08/06/2024, with responses due 08/09/2024. No responses were received.

11. Actions Taken to Remove Barriers to Future Competition At this time, there are no known future requirements. This justification covers the only known requirement. If a future need is discovered, market research will need to be conducted to identify potential sources at that time.