Notice of Intent to Sole Source: Mammalian Cell Culture Metabolite and Cell Count Analysis System (BioProfile® FLEX2 analyzer)

The National Institute of Standards and Technology (NIST) intends to negotiate on a sole source basis, under the authority of FAR 13.106-1(b)(1), with: Nova Biomedical Corp 200 Prospect St Waltham, Massachusetts 02453-3457 The sole source justification is based on the following:

The National Institute of Standards and Technology (NIST) Biomolecular Measurement Division (BMD) has a need for new, modernized capabilities for mammalian cell culture characterization and analysis to include rapid, "on-line" measurements that can be conducted during bioprocesses in support of the ongoing NIST Biomanufacturing Program. Achieving "on-line" measurements requires capabilities for integration with commercial automated sterile bioreactor (ASR) sampling systems.

The Biomolecular Structure and Function (BSF) group within the BMD currently operates multiple bioreactor systems for mammalian cell culture and is actively working to incorporate two of these bioreactors into a Bioprocess Digitalization Testbed activity.

At present, the BSF group lacks capabilities to perform rapid at-line measurements of cell culture cell counts, metabolites, chemistry, etc. Based on market research, NIST has determined that Nova Biomedical is the only vendor that manufactures a Bioanalyzer that performs all of the needed measurements as a single instrument and is compatible with integration into commercial ASR sampling systems.

Although multiple commercial instruments in combination could be used to enable these capabilities, performing all of the measurements would require purchasing and operating three unique instruments. This could meet a need for "at-line" measurements.

However, the use of three instruments would degrade or prevent NIST's ability to achieve the needed "on-line" measurements since (1) a useful combination of three instruments is not currently known that is compatible with commercial ASR sampling systems, (2) using three instruments, as opposed to one, to meet the need is expected to require more investment in data infrastructure and handling to achieve an integrated system and (3) even if a combination exists, three unique instruments, as opposed to one, would occupy a majority of the capacity of the ASR sampling system and prevent automated sampling for novel measurements and analytical technologies to be developed by the Testbed.

The only solution that meets the government's need in its entirety is the purchase of a single instrument performing all needed measurements and compatible with integration, as a single instrument, with commercial ASR sampling systems. Nova Biomedical does not work with any 3rd party vendors/distributors. This information is included in a sole source letter provided by Nova Biomedical. Given these facts, Nova Biomedical is the only source reasonably available to fulfill the requirement.

The resulting purchase order will be a Firm Fixed Price purchase order. The NAICS Code is 334156 Analytical Laboratory Instrument Manufacturing with a size standard of 1,000 employees. No solicitation package will be issued. This notice of intent is not a request for competitive quotations; however, interested parties who regard themselves as capable of fulfilling these requirements are invited to submit responses to the Government for consideration.

Responses received by 9:00 Am EST June 6, 2024, will be considered by the Government. Responses must be submitted via email to the Government point of contacts listed below. A determination by the Government not to compete the proposed acquisition 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 competitive procurement.