Zetasizer Sample Handler Assistant for an existing Zetasizer zeta potential measurement instrument system

PRE-SOLICITATION NOTICE **NOTICE OF INTENT TO SOLE SOURCE NOI-NIAID-24-2228973 NAICS – 334516 This is a Notice of Intent, not a request for proposal.

The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Malvern Panalytical Inc to purchase upgrade equipment, a Zetasizer Sample Assistant, for an existing Zetasizer zeta potential measurement instrument system in use by the Vaccine Research Center (VRC) Vaccine Production Program (VPP).

The mission of the Vaccine Production Program (VPP) at the Vaccine Research Center (VRC) is to develop production processes for vaccine candidates. The VPP requires the procurement of an automated sample handler for the existing Zetasizer zeta potential measurement system. The zeta potential measurements system is currently used to develop and execute analytical methods to support the characterization, formulation and stability of biologic molecules produced by the VPP.

This ensures that the results of the production processes meet requirements for batch conformity, safety and stability. The current instrument for measuring zeta potential measures samples singly requiring manual sample prep and initiation processes that are time consuming and result in limited throughput. The VPP requires a higher throughput system to accommodate the large number of the analyses inherent to the mRNA-LNP development program ongoing at the VRC.

The procurement of the Zetasizer Sample Assistant will automate zeta potential measurements on the Zetasizer, reducing operator time and increasing throughput by enabling overnight analyses. The Zetasizer Sample Assistant (manufactured by Malvern Panalytical) is an automated sample handler designed for specifically for use in automating measurements on the Zetasizer zeta potential instrument.

Since the VPP already utilizes the Zetasizer instrument for zeta potential measurements, incorporating this accessory would enable automated measurements without the need for additional instrumentation purchases. Currently, no other sample handlers on the market are compatible with the Zetasizer. There are no alternate options on the market for automated zeta potential measurements able to provide comparable data to the Zetasizer in terms of data quality, precision, and accuracy.

In addition, the estimated cost of moving to a different platform is estimated to be~ $300,000, as it would require purchase of new instruments at both the VPP and at the VRC Pilot Plant (instrumentation must be aligned between develo0pmetn and GMP manufacturing sites), and there are additional cost associated with developing new methods for new instrumentation at both sites. The statutory authority for this sole source requirement is 41 U.S.C.

1901(e)(2) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL.

All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-24-2228973) to Dana Monroe at dana.monroe@nih.gov by 5:00 pm eastern time Monday, July 2, 2024. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.