Protein Production and Purification for USAMRICD

This notice announces the intent by the U.S. Army Medical Research Acquisition Activity (USAMRAA), in support of the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD), to issue a sole source, firm-fixed priced (FFP) solicitation HT9425-24-Q-XXXX for the service requirement for the ability to be self-sufficient in protein production and to sustain research operations leveraging a highly specific purified recombinant human acetylcholinesterase enzyme currently being used at the USAMRICD.

The authority for the sole source justification and other than full and open competition procedures will be in accordance with (IAW) FAR 13.106-1(b)(1), soliciting from a single source, for purchases not exceeding the simplified acquisition threshold. This notice serves as the Government's notice of intent.

The USAMRICD requires the ability to generate highly purified recombinant human acetylcholinesterase suitable for use in research to measure continued function of the protein as part of critical in vitro biochemical activity assays. The procurement of this service would allow the government to be self-sufficient in protein production.

The enzyme product must comprise the enzyme amino acid sequence for the human form, be soluble in aqueous solution generally in a monomeric form with no anchoring components, maintain enzymatic activity against the nominal substrate, and be expressed in a system that does not drastically alter the post-translational modification pattern associated with the human-expressed enzyme. The enzyme must be available at >90% purity and retain hydrolytic activity.

The enzyme will be used in research efforts that require the measurement of hydrolytic activity using standard biochemical assaying techniques. The enzyme is critical for the evaluation of novel drugs. The enzyme is required continuously as assaying is done on a routine basis. Since the government requires a consistent supply of the enzyme, the knowledge to generate the enzyme (given the impending dissolution of a current major source) is required.

The supplier must supply a reasonable amount of material (i.e., able to be tested for activity using standard in vitro activity assay techniques) as well as the knowledge and training to create duplicate material at the USAMRICD located at Aberdeen Proving Ground, MD. Traditionally, a source of high quality purified human acetylcholinesterase has been difficult to identify.

While most commercially available versions of the enzyme are catalytically active (examples include Sigma Aldrich C1682 and Fisher Scientific 7574CE010), they are not robust enough to undergo inhibition and subsequent preparation for reactivation assays (previous testing has shown significant loss of material during a critical buffer exchange step of preparation).

Additionally, the cost of the alternative commercially available enzymes has historically inhibited the amount of testing that can be conducted and would not allow the laboratory to meet the current levels needed to meet mission requirements without substantial additional cost to the government. The human acetylcholinesterase enzyme is critical for an on-going project that is expected to continue for at least three years.

Additionally, other projects within the DoD enterprise utilize the same enzyme for additional projects. Until recently, the enzyme product has been made available using an established government contract (GS-07F-5934R) with a fixed price per milligram. However, the primary manufacturer of this product has indicated it will dissolve soon, and USAMRICD will not be able to meet critical research milestones and work involved with these enzymes will cease.

Failure to award a contract will jeopardize mission success, delay achievement of crucial research milestones and risk future funding. The North American Industry Classification System (NAICS) for this requirement is 541715, Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) and a Small Business Size Standard of 1,000 in number of employees.

The Product Supply Code (PSC) is AJ11, General Science And Technology R&D Services; General Science And Technology; Basic Research This Notice of Intent announcement is for the ability to be self-sufficient in protein production, generating highly purified recombinant human acetylcholinesterase, suitable for use in research, to measure continued function of the protein as part of critical in vitro biochemical activity assays and is not a request for competitive quotations.

However, the Government will consider all responses received. The Government will not be responsible for any cost incurred in preparation of quotations. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a subsequent competitive procurement.

All interested parties may submit a response for consideration and identify their capability (formats for submission: PDF, MS Word, or MS Excel) by e-mail only to Mr. Kenneth Grenier, Contract Specialist, at email: kenneth.e.grenier2.civ@health.mil , by 18 February 2024 at 12:00 PM (Noon) Eastern Time.