Intent to Sole Source: One (1) Tangential Flow Filtration System (TFF)

The Center for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases Influenza Division (NCIRD/ID), intends to award a sole source purchase order in accordance with FAR 13.106-1(b)(1), soliciting from a single source, to Formulatrix, LLC of 5 DeAngelo Dr., Bedford, MA 01730, for the purchase of one (1) TFF system, along with training and Install Qualification and Operation Qualification (IQOQ).

The NAICS code for this procurement is 334516, Analytical Laboratory Instrument Manufacturing. The purpose of this acquisition is to procure a small machine that can purify and concentrate proteins, viruses, and RNA to meet vaccine development needs at a reasonable price. Furthermore, this machine should be Good Laboratory Practice (cGLP) compliant as dictated by the FDA. The vendor will also be required to provide training and Install Qualification and Operation Qualification (IQOQ).

Tangential Flow Filtration (TFF) systems were identified as the preferred class of equipment for this requirement. Formulatrix provides a valid TFF system at a reasonable price that meets technical capability and regulatory compliance. Further, the Formulatrix Upulse system is the only known system with an entirely disposable flow path, which allows the sample tubing, the pump, and the membrane to be reused or replaced between samples.

Consequently, Formulatrix is being considered for a sole-source award for the uPulse system to fulfill this requirement. As a result of this notice, no competitive solicitation will be posted on SAM.gov.

The government will issue only one solicitation to Formulatrix, LLC. However, firms that believe they can meet this requirement are encouraged to identify themselves and give written notice by providing a capability statement to the contract specialist, Dawnnia Daley, at xwf5@cdc.gov by July 18, 2024, at 5:00 p.m. EDT. The contract specialist will not respond to verbal requests. All requests must be in writing.

A determination by the government not to take this proposed action will be based on responses to this notice and is solely within the discretion of the contracting officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Inquiries shall reference the solicitation number, 75D301-24-Q-77938, on the subject line and be sent to Dawnnia Daley by email at xwf5@cdc.gov.