Knauer branded IJM NanoScaler
Waiver type - Procurement: Nonavailability
Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 08/29/2023
Procurement Summary
NIAID requires the IJM Nanoscaler system and accompanying components made by the company Knauer in Germany. National Institute of Allergy & Infectious Diseases (NIAID)’s Vaccine Research Center (VRC) (collectively “Program”) is engaged in research to facilitate the development of vaccines against HIV/AIDS and other infectious pathogens/diseases. Program is researching mRNA technology as a current and attractive alternative for the development of Human vaccines. The target protein gene sequence is encoded in a template DNA plasmid containing a T7 RNA polymerase promoter required for RNA transcription. The mRNA transcripts are produced from a linear DNA template during an in vitro transcription (IVT) reaction. The resulting mRNA is subsequently purified, formulated in lipid nanoparticles, and delivered into cells to be translated into the protein of interest. Program requires the Knauer IJM Nanoscaler to further its research. The IJM Nanscaler is designed for lipid nanoparticle R&D – allowing scientists to screen for the optimal process parameters for the formulation of API-containing lipid nanoparticles. This acquisition has unique requirements. Knauer is the only manufacturer of this custom IJM Nanoscaler system that is required by the Program to implement its available mRNA production technology for clinical development. The Knauer IJM Nanoscaler is a production scale instrumentation and fulfills the missing piece in Program’s ability to scale both process development and the clinical manufacturing needed to support NIH programs. The volume scale required for Program’s work is met by the Knauer IJM Nanoscaler at 15mL to 1L. This instrument and software is CFR 21 compliant. Knauer IJM Nanoscaler provides instrumentation and software solutions to enable scaling from benchtop to clinical manufacturing with minimal development between scales, thus creating significant time and overall cost savings for Program. The requested instrument will serve for development work at the VRC and GMP scale production at the Vaccine Clinical Materials Program (VCMP), and will provide the highest chance of success to meet the VRC’s mission. The Knauer IJM Nanoscaler also meets the following technical requirements that is required by Program: 1. Microfluidic Channels are Required 2. Impingement Jet Mixing Technology is Required and Non-Substitutable 3. Operational Pressure Capacity at ~100 bar is Required 4. Operational Volumetric Range encompassing 15 mL to > 1 L Production Runs is Required 5. Temperature Control of Post Mixing Chamber Flow Path is Required 6. Encapsulation Efficiency > 90% is Required 7. Linear Scale Up from Development to Production Scale is Required 8. Identical Software Supporting Development and Production Platforms is Required 9. 21 CFR Compliance is Required 10. IQOQ Availability is Required 11. Mobile Platform With a Minimal Footprint is Required 12. Stainless Steel Construction is Required 13. In Line Absorbance Detection is Required To our knowledge, only this IJM Nanoscaler platform from Knauer can meet the requirements of Program, and this platform is made in a foreign country of Germany.
Waiver Rationale Summary
Based on the above market research findings and results from the sources sought was posted on SAM.gov under SS-NIAID-23-2168438 from 7/08/2023-7/14/2023 and from the current RFQ that was posted, no domestic products that meet the requirements were available. No domestically manufactured items that meet the Government’s need that are mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of satisfactory quality could be identified. Only one company responded to the solicitation (Request for Quotes), which was posted as full and open competition with a brand name or equal requirement, and that was Knauer. The feasibility of foregoing the requirement or providing a United States manufactured substitute has been considered, and no substitutes were found. Authority is requested to acquire the above-described Nanoscaler, manufactured by Knauer in Germany. Based on the findings detailed above, the Nanoscaler, manufactured by Knauer are not mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Therefore, it is hereby determined by NIAID, consistent with FAR 25.103(b)(2), that these items are not domestically available.
Yes
Yes
Consistent with Policy
LABORATORY EQUIPMENT AND SUPPLIES
334516 - Analytical Laboratory Instrument Manufacturing
08/22/2023
RFQ-NIAID-23-2168438
SS-NIAID-23-2168438
RFQ-NIAID-23-2168438
Post-solicitation
0 - 6 months
Individual Waiver
NATIONAL INSTITUTES OF HEALTH