MODIFICATION
66 -- Knauer branded IJM NanoScaler (Brand Name or Equal)
- Notice Date
- 8/14/2023 1:01:01 PM
- Notice Type
- Combined Synopsis/Solicitation
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- RFQ-NIAID-23-2168438
- Response Due
- 8/31/2023 8:00:00 AM
- Archive Date
- 09/15/2023
- Point of Contact
- Lu Chang, Phone: 2406273034
- E-Mail Address
-
lu-chang.lu@nih.gov
(lu-chang.lu@nih.gov)
- Description
- This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedures. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 �Streamlined Procedures for Evaluation and solicitation for commercial Items,� as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation (a written solicitation will not be issued) and quotes are being requested. The Solicitation number is RFQ-NIAID-23-2168438 and the solicitation is issued as a Request for Quotes (RFQ). This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-04 dated 6/02/2023.� The North American Industry Classification System (NAICS) code for this procurement is NAICS 334516 - Analytical Laboratory Instrument Manufacturing (size standard 1,000).� The requirement is being competed as a Brand Name or Equal requirement (considered full and open competition), and without a small business set-aside. 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 NanoScaler 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 National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for the following equipment (Brand Name or Equal): Knauer IJM NanoScaler system and accompanying components.� See the attached Bill of Materials (BOM) with full details of part numbers, line item description, and quantity.� 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 Delivery Date/Period of Performance: Delivery is estimated four (4) months after date and receipt of award. Shipping/Delivery: FOB Point shall be Destination, Gaithersburg, MD 20878.� Place of delivery is Vaccine Production Program (VPP), 9 West Watkins Mill Road, Suite 200/250, Gaithersburg, MD 20878.� All equipment delivered shall contain a Packing Slip (with serial numbers when applicable). The government intends to award a �firm fixed price� purchase order to the responsible contractor as a result of this RFQ that will include the terms and conditions set forth herein.� The award will be based on the technical capability to meet the requirements and price.� NIAID will evaluate quotes to determine the best value to the government.� NIAID will evaluate price only for those quotes, which are rated as technically acceptable. In the event quotes are evaluated as technically equal, price will become a major consideration in selecting the successful Offeror. The following FAR provisions apply to this acquisition: FAR 52.212-1 Instructions to Offerors Commercial Items FAR 52.212-3 Offerors Representations and Certifications - Commercial Items FAR 52.204-7 System for Award Management (Offerors must complete annual representations and certifications on-line at http://www.sam.gov/ in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items (Please ensure 52.209-2 -- Prohibition on Contracting with Inverted Domestic Corporations--Representation. FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements � Representation FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment 52.204�26 Covered Telecommunications Equipment or Services-Representation FAR 52.211-6 Brand Name or Equal As prescribed in 11.107(a), insert the following provision: Brand Name or Equal (Aug 1999) (a) If an item in this solicitation is identified as ""brand name or equal,"" the purchase description reflects the characteristics and level of quality that will satisfy the Government�s needs. The salient physical, functional, or performance characteristics that ""equal"" products must meet are specified in the solicitation. ����� (b) To be considered for award, offers of ""equal"" products, including ""equal"" products of the brand name manufacturer, must- ���������� (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; ���������� (2) Clearly identify the item by- �������������� (i) Brand name, if any; and �������������� (ii) Make or model number; ���������� (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and ������ ����(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications. ����� (c) The Contracting Officer will evaluate ""equal"" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. ��� ��(d) Unless the offeror clearly indicates in its offer that the product being offered is an ""equal"" product, the offeror shall provide the brand name product referenced in the solicitation. The following FAR contract clauses apply to this acquisition: FAR 52-212-4 Contract Terms and Conditions Commercial Items FAR 52-212.5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors FAR 52.204-13 System for Award Management Maintenance FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations 52.252-2 -- Clauses Incorporated by Reference. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:� http://farsite.hill.af.mil/vffara.htm. By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov). Copies of the above-referenced provisions and clauses are available from http://www.acquisition.gov/far/loadmainre.html & http: //www.hhs.gov/regulation/index.html or, upon request, either by telephone or fax. Submission shall be received not later than 08/31/2023 @ 11:00 AM EST All interested offerors shall provide a Quote to include a point of contact (name, phone number & email) and company information (Unique Entity Identifier (UEI) and Cage Code).� Each response must clearly indicate the capability of the vendor to meet all specifications and requirements.� State whether the Offeror is the manufacturer and include Country of Origin information.� The Government may evaluate only those quotes that fully meet the requirements as outlined and respond to the solicitation instructions and requirements.� Failure to furnish a full and complete quote as instructed may result in the Vendor being considered non-responsive and eliminated from further consideration and award. Offers may be emailed to Lu Chang at � by 11:00 am eastern standard time August 31, 2023.� Offers shall include RFQ number in the subject line (RFQ-NIAID-23-2168438).� Late submission shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All responsible sources may submit an offer that will be considered by this Agency.� Any questions or concerns regarding this solicitation should be forwarded in writing via email to Lu Chang at lu-chang.lu@nih.gov.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/162dea119cef4a68b02fda9f486b51b6/view)
- Place of Performance
- Address: Gaithersburg, MD 20878, USA
- Zip Code: 20878
- Country: USA
- Zip Code: 20878
- Record
- SN06788462-F 20230816/230814230046 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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