SOLICITATION NOTICE
Q -- Synthesis of Thyclotides (R,R) and (S,S)-trans-Tetrahydrofuran- constrained peptide nucleic acids
- Notice Date
- 8/3/2022 4:57:56 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 54138
—
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NICHD BETHESDA MD 20817 USA
- ZIP Code
- 20817
- Solicitation Number
- NICHD-22-231-1
- Response Due
- 8/14/2022 8:00:00 AM
- Archive Date
- 08/29/2022
- Point of Contact
- GRIFFIN, VERNE L, Phone: 3015947730, HAUN, PATRICIA M, Phone: 13014437786
- E-Mail Address
-
verne.griffin@nih.gov, haunp@mail.nih.gov
(verne.griffin@nih.gov, haunp@mail.nih.gov)
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice.� This announcement constitutes the only solicitation, and a separate written solicitation will not be issued.� This solicitation number isNICHD-22-229 and is issued as a Request for Quotation (RFQ).� The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2022-06.� The North American Industry Classification (NAICS) Code is 54138 and the business size standard is $15.0M.� It is the intent of The National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK) to award a purchase order, without providing for full and open competition, to Frontage Laboratories, Inc., 700 Pennsylvania Drive, Exton, PA 19341, for Synthesis of Thyclotides (R,R) and (S,S)-trans-Tetrahydrofuran- constrained peptide nucleic acids. Chemists in the NIDDK have designed and synthesized a series of new molecules called thyclotides.� Some of these molecules are potential components for diagnostic kits to be used for the rapid detection of nucleic acids associated with diseases.� The development of new diagnostic kits to signal the early stages of infections or cancers could be of great benefit to human health and thus to NIDDK's mission. In order to make thyclotides and cyclopentane peptide nucleic acids and study their binding to nucleic acid sequences, it is essential to have the correct starting materials.� The NIDDK lab has shown that the incorporation of trans-cyclopentane diamine into PNA backbones improves binding to target nucleic acid sequences. Our research on cyPNA and thyclotide development for the detection of nucleic acids associated with diseases therefore depends on the purchase of the chemicals to be custom synthesized in this order. Substantial in vitro work has been done to select cyPNAs to move forward as probes for diseases, which has incurred substantial investment that will be applied to the new class of thyclotide molecules. Contractor must carefully follow confidential synthetic protocols from the NIDDK lab and provide written documentation of all deviations from established protocols. Experience in drug synthesis and compliance with FDA requirements and drug development protocols is required. Final products must be delivered with requested quantity for each molecule, with purity in excess of 98%. Final products will be analytically tested by NIDDK before final acceptance. Scale of synthesis for the target molecules is not possible in NIDDK labs due to space limitations. Obtaining synthesis service will allow NIDDK lab to pursue advanced experiments without needing to continually repeat established protocols over and over again.�� The Contractor shall: ����������� Starting with the synthetic routes provided by the NIDDK, scale up the synthesis of thyclotide(T), thyclotide (A(Bhoc)), thyclotide (C(Bhoc)), thyclotide (G(Bhoc)), to produce 10 g of each molecule as the methyl ester � the final hydrolysis will not be performed. ����������� Purify each molecule via recrystallization or silica gel chromatography ����������� Synthesis may be performed in batches.� A complete certificate of testing (Analysis) will be provided for each synthetic batch ����������� Provide 10 g of each final compound a glass or plastic canister inside a protected shipping box or package to NIDDK investigator ����������� Perform characterization by NMR and check purity by MS for COT ����������� Provide a Certificate of Analysis (COA) for each molecule synthesized (per batch) TASK AREAS: Task Area 1 � The Contractor shall deliver final products to NIDDK no later than 3 months after award.� Task Area 2 � The Contractor shall prepare THF-PNA monomers (10 grams of each) for NIH. The final products will be methyl esters (hydrolysis not to be performed). Starting material and all nucleobase acetic acids, including T-CH2-CO2H, A(Bhoc)-CH2-CO2H, C(Bhoc)-CH2-CO2H, and G(Bhoc)-CH2-CO2H will be provided by NIH/NIDDK. Any previously synthesized reference compounds of interest will be provided by NIH/NIDDK, if readily available. The Contractor shall provide supporting mass spectral, NMR spectroscopy and purity data (HPLC/UV, % area) for the subject compounds. An analytical HPLC/MS/UV method will be set up to characterize all sixteen monomers. The Contractor shall deliver 10 g of each final compound in a glass or plastic canister inside a protected shipping box or package to NIDDK investigator (agreed to by the Contractor and Program Officer) on NIH campus. The Contractor shall take approximately 10-12 weeks to synthesize and purify the compounds from approval of the work order. The offeror must include a completed copy of the following provision�s along with their quote:� FAR Clause 52.212-3, Offeror Representations and Certifications � Commercial Items; FAR Clause 52.204-24, Representation Regarding Certain Telecommunication and Video Surveillance Services or Equipment; FAR Clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. ��The provisions of FAR Clause 52.212-1 Instructions to Offerors � Commercial Items; FAR Clause 52.212-2, Evaluation � Commercial Items: Evaluation Factors (1) technical capability to provide all services/consumables, etc.; (2) price; and (3) past performance. Technical capability and past performance, when combined, are significantly more important than cost/price; FAR Clause 52.212-4, Contract Terms and Conditions � Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders � Commercial Items � Deviation for Simplified Acquisitions applies to this acquisition, apply to this acquisition.� The offeror must include their Unique Entity ID: (UEI), the Taxpayer Identification Number (TIN), and the certification of business size.� The clauses are available in full text at http://www.arnet.gov/far.� Interested vendors capable of providing the Government with the services specified in this synopsis should submit their quotation to the below address.� Quotations will be due ten (10) calendar days from the publication date of this synopsis or August 14, 2022 at 11:00 AM.� The quotation must reference �Solicitation number� NICHD-22-229.� All responsible sources may submit a quotation, which if timely received, shall be considered by the agency.� Quotations must be submitted by email to Verne Griffin at verne.griffin@nih.gov.��� Faxed copies will not be accepted
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- SN06412424-F 20220805/220803230110 (samdaily.us)
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