A02 Part 13 _ JA Sole Source FAR Part 13.5 V3 Oct 2023 BioReactor Final 26 Jun 24-Redacted.pdf

CUI

Control Number: JA-24-05-1549

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: United States Army Medical Research Acquisition Activity (USAMRAA) on behalf of the Walter Reed Army Institute of Research (WRAIR)

2. Description of Action: This requirement is for a new contract with Eppendorf to purchase a 120L BioFlow Pro Bioreactor/Fermenter system to include shipping, installation, training, and one year manufacturer warranty. will be utilized.

3. Description of Supplies/Services: The Pilot Bioproduction Facility (PBF) requires a 120L Bioreactor/Fermenter for use in Good Manufacturing Practice (GMP) production of bacteria and bacterial produced products to be used in Phase 1 clinical trials. This requirement will include equipment, installation and a one-year service contract and total estimated to be approximately

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial.

5. Reason for Authority Cited: Only one source can provide equipment that meets all essential requirements. The BioFlo Pro 120 system is a configured piece of equipment that is proprietary to the original equipment manufacturer (OEM) Eppendorf.

The WRAIR PBF manufactures vaccines for Phase 1 clinical studies, typically at small scale. To mitigate cross-contamination risks between different vaccine products, stainless steel bioreactors are necessary. They're durable, withstand rigorous cleaning and sterilization processes and their reusability and pre-set options allow for flexible process optimization.

Controlled by: Defense Health Agency (DHA) Controlled by: USAMRAA CUI Category(ies): Source Selection Limited Dissemination Control: FED Only

POC:

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Source Selection Information - See FAR 2.101 and 3.104-4

This requirement is for a replacement of an existing BioFlo Pro 75 system currently in use at the PBF for fermentation of GMP produced vaccine products. The PBF also currently uses the BioFlo PRO 400 for large scale fermentations and the BioFlo 320 for small scale and development runs. The BioFlo Pro 120 system meets all requirements for process transferability, system/software integration and production scale. Due to the nature of research, materials and for continuity of SOPs and technical knowledge with this equipment. This item is proprietary to the manufacturer and is a custom configuration product.

The 120L Bio Flow Pro system will integrate seamlessly with PBF current processes and standard operating procedures as the equipment construction and software are the same as the PBF’s existing fermenters. This consistency and operator familiarity will minimize risk to equipment, product, and indviduals that can be caused by switching between different control schemes and equipment. Introducing dissimilar equipment would also necessitate the development, rewriting, and approval of new Standard Operating Procedures (SOPs), leading to increased training needs, labor hours, and costs.

Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201 and any responses received shall be considered. A Request for Information (RFI) was posted on SAM.gov from 11 June 2024 to 13 June 2024, there were no capabilities statements received. A Notice of Intent (NOI) was posted to SAM.gov for 15 days, from 30 May 2024 to 13 June 2024 and no responses were received. This item is proprietary to the OEM and No efforts to obtain competition can be performed.

Actions to Increase Competition:

Actions to increase competition is not possible since the required equipment are propriety to Eppendorf. No steps at this time can be taken to increase the competition given that Eppendorf is the only source that can provide the proprietary piece of equipment needed.

8. Market Research: Market research conducted between June 2023 through October 2023 in accordance with FAR part 10 and reflected that only the manufacturer can supply this equipment with the configurations and materials needed, at a reasonable cost, while seamlessly integrating with current PBF technology, control systems, and approved processes and procedures required to maintain continuity within the Requiring Activity.

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Source Selection Information - See FAR 2.101 and 3.104-4

Market research identified three (3) manufacturers of bioreactors. Sar ious, manufactures bioreactors but informed the Government that they no longer intend to manufacture stainless steel vessels and their market focus is on single-use platforms.

Not Biocommand software compatible. The other manufacturers ABEC, noted that they could provide a custom-built platform, but informed the PBF that they could not be cost-competitive with other options that are currently on the market because they only provide custom built systems. Not Biocommand software compatible.

Only Eppendorf meets all of the minimal essential characteristics for the the required equipment and services.

9. Interested Sources: To date, there have been no other interested sources.

10. Other Facts: There is no procurement history for this equipment.

a. Procurement history.

(1) Contract numbers and dates of all awarded contracts for these same requirements. – Not Applicable

(2) The competitive status of these actions. – Not Applicable

(3) Authority previously cited if less than full and open competition was used. – Not

Applicable

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. – Not Applicable

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. – Not Applicable

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. – Not Applicable

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. – Not Applicable

b. Other facts. – None